Medical Injection Molding Companies

Last updated: January 2026

This directory lists 93 medical injection molding companies across the United States, from specialized regional providers to large-scale national operations.

Buyers in the medical injection molding space are primarily solving challenges related to stringent regulatory compliance, achieving sub-micron dimensional tolerances on complex geometries, and ensuring material biocompatibility for patient contact applications. The ability to consistently control particulate contamination within an ISO Class 7 or 8 cleanroom environment, coupled with expert Design for Manufacturability (DFM) feedback tailored for sterile or implantable devices, differentiates a capable molder from a general industrial one.

Supplier types in this sector range from highly specialized cleanroom molders focusing solely on implantable components with intricate micro-molding capabilities, to full-service contract manufacturers offering integrated assembly, packaging, and sterilization management. There are also niche molders specializing in specific polymer types like PEEK or resorbable materials, and larger enterprise-level partners capable of managing global supply chains and high-volume, multi-cavity tooling projects across various therapeutic areas.

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Company Directory

93 companies nationwide

Aberdeen Technologies, Inc.

aberdeentech.com
Carol Stream, IL

Based in Carol Stream, IL, Aberdeen Technologies, Inc. provides medical device injection molding services, producing high-precision plastic components for the healthcare industry. They adhere to strict regulatory standards, offering capabilities for FDA-approved devices, clean-room manufacturing, and sterilization, supporting both production and prototyping needs.

sales@aberdeentech.com+16306658590

ACI Medical, LLC

acimedical.com
San Marcos, CA

Based in San Marcos, CA, ACI Medical, LLC provides custom injection molding services, focusing on medical, industrial, and consumer products. Their modern CAD/CAM tool room handles low-cost aluminum tooling. They utilize FDA resins and offer secondary operations, including assembly and part printing.

info@acimedical.com+17607444400

Advanced Plastiform, Inc.

advancedplastiform.com
—

Advanced Plastiform, Inc. offers medical injection molding services, focusing on efficiency, precision, and timely delivery for medical device manufacturing and healthcare components. The company also provides injection molding and thermoforming for other sectors, including automotive, construction, transportation, and material handling applications.

andrew@theedigital.com+19194042080

AJ Medical Manufacturing

ajmedusa.com
Houston, TX

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer specializing in medical devices and components. They utilize an agile and vertically integrated manufacturing approach to shorten time to market for customer partners.

info@ajmedusa.com+18443188784

American Medical Molding LLC

americanmedicalmolding.com
Houston, TX

Based in Houston, TX, American Medical Molding LLC specializes in ISO 13485 certified medical injection molding. They operate a Class 8 cleanroom, manufacturing components for medical disposables, surgical devices, drug delivery, and wearables. Services encompass complex overmolding, automation, secondary operations, and full verification and validation studies.

micah@micahrich.com+17133771840

Aprios

aprios.com
Minneapolis, MN

Based in Minneapolis, MN, Aprios specializes in precision injection molding for the medical device sector. The company is ISO 13485 certified, FDA registered, and operates ISO Class 8 Clean Rooms. Their Vista, California facility features JSW electric presses, providing local production for critical clean-room components and DFM for medical devices.

sales@aprios.com+17632972613

Aptyx

aptyx.com
Tempe, AZ

Based in Tempe, AZ, Aptyx specializes in complex injection molding, extrusion, and coating services. The company provides cutting-edge solutions, including medical device assembly, for diverse industries. Aptyx focuses on partnering with clients to deliver advanced manufacturing capabilities for demanding applications.

info@aptyx.com+18008521472

Arterex

arterexmedical.com
—

Arterex provides comprehensive medical device contract manufacturing, from components to Class I, II, and III devices. Capabilities include high-precision, tight-tolerance injection molding, tubing extrusion, and metal fabrication. Certified ISO 13485, FDA registered, and operating clean rooms, Arterex serves clients globally from facilities in North America, Europe, Asia, and North Africa.

inquiries@arterexmedical.com+14803445000

ASH Industries

ashindustries.com
Lafayette, LA

Lafayette, LA-based ASH Industries provides ISO 13485 certified medical injection molding services, utilizing an ISO Class 7 cleanroom. They offer plastic, metal, and silicone molding, in-house tooling, overmolding, DFM, and secondary operations. Their team supports prototyping and low-volume production.

info@ashindustries.com+13372350977

ASPEC

aspecplastics.com
Cincinnati, OH

Based in Cincinnati, OH, ASPEC provides custom plastic injection molding and tooling services. They offer full-service options including design, mold build, fabrication, and machining, working with high-grade materials. Serving diverse industries like medical, aerospace, and automotive, ASPEC produces molds up to 30″ in length for various applications.

info@aspecinc.com+15135619922

Atalys

atalys.com
—

Atalys provides vertically integrated medical device contract manufacturing services. The company specializes in highly engineered tooling design, mold making, and extreme precision plastic injection molding for the medical device industry. It produces highly engineered components and precise parts for critical surgical applications.

info@atalys.com+15856472300

Biomerics

biomerics.com
Salt Lake City, UT

Based in Salt Lake City, Biomerics is a vertically integrated medical device manufacturer and contract partner. They offer end-to-end capabilities, from raw polymers to finished devices, including polymer and metal expertise. The company specializes in engineering and manufacturing complex interventional components and devices.

info@biomerics.com+18888747787

Biotex Inc.

biotexmedical.com
Houston, TX

Based in Houston, TX, Biotex Inc. is an ISO-certified and FDA-registered CDMO specializing in medical device design and manufacturing. With 25+ years of expertise, they transform innovative ideas into life-changing solutions, leveraging their robust design, engineering, and manufacturing capabilities for patient care.

criterion@biotexmedical.com+17137410111

BMF Devices

bmfdevices.com
Miamisburg, OH

Based in Miamisburg, OH, BMF Devices offers comprehensive plastic injection molding services, leveraging over 40 years of experience. They provide in-house mold creation and part production, utilizing 28 presses from 40 to 1,000 tons. BMF specializes in quality-controlled manufacturing for diverse industries, including medical devices.

gary@bmfdevices.com+19378663451

Boedeker Plastics, Inc.

boedeker.com
Shiner, TX

Boedeker Plastics, Inc. based in Shiner, TX, is a USA-owned and ISO certified custom injection molder specializing in high-performance plastics. They provide precision manufacturing for critical applications, including medical and life sciences devices. With expertise in engineering-grade thermoplastics, the company serves demanding sectors like aerospace, semiconductor, and industrial equipment.

ecom@boedeker.com+18004443485

Cary Products

caryproducts.com
Hutchins, TX

Based in Hutchins, TX, Cary Products is an ISO 9001:2015-certified plastic manufacturer specializing in custom injection molding and thermoforming. They provide durable solutions for various industries, including medical, automotive, and HVAC sectors. The company leverages advanced 3D design and extensive tooling capabilities for precise part production.

info@caryproducts.com+19722254271

Central Plastics Manufacturing

centplasticmfg.com
Tracy, CA

Based in Tracy, CA, Central Plastics Manufacturing is an ISO 13485 certified medical molder with a Class 8 clean room and CE molding facility. They specialize in plastic injection molding for diverse medical components, including single-use devices, catheter housings, diagnostic consumables, and surgical instrument parts. They utilize medical-grade plastics for healthcare applications.

info@centplasticmfg.com+12095325146

C&J Industries

cjindustries.com
Meadville, PA

Based in Meadville, PA, C&J Industries specializes in high-precision medical injection molding and plastic contract manufacturing. They offer a full range of services, including assembly, decorating, and tooling, for medical and pharmaceutical sectors. The company is ISO 13485 and FDA registered, utilizing Class 7 & 8 cleanrooms for medical device component production.

sales@cjindustries.com+18147244950

Control Plastics and Metals

controlplastics.com
Menlo Park, CA

Based in Menlo Park, CA, Control Plastics and Metals provides custom plastic injection molding and metal components. They specialize in medical devices, offering prototyping and production services for over 40 years. The company is ISO 9001 and 13485 certified, and FDA registered, ensuring quality for critical applications.

sales@controlplastics.com+16502220066

Currier Plastics

currierplastics.com
Auburn, NY

Based in Auburn, NY, Currier Plastics provides custom injection molding solutions for medical devices and pharmaceuticals. They operate ISO Class 8 cleanrooms and are ISO 13485 certified, ensuring high-quality manufacturing in controlled environments for sensitive applications within the healthcare market.

info@currierplastics.com+13152551779

Damar Plastics

damarplastics.com
El Cajon, CA

Based in El Cajon, CA, Damar Plastics is an injection molding manufacturer specializing in plastic injection and blow molding services. The company offers design, mold manufacturing, and value-added solutions, catering to customers in San Diego and Southern California, including those in the medical device industry.

sales@damarplastics.com+16192832300

D&M Plastics, LLC

dmplastics.com
Burlington, IL

D&M Plastics, LLC, based in Burlington, IL, provides plastic injection molding for medical and dental parts. They manufacture high-precision components adhering to strict FDA standards, producing elaborate designs quickly and cost-effectively. The company is ISO 9001:2015 and ISO 13485:2016 QMS certified.

salesusa@jbtecnics.com+18476832054

Eagle Mold Co., Inc.

eaglemoldcompany.com
Carlisle, OH

Based in Carlisle, OH, Eagle Mold Co. Inc. provides plastic injection mold design and build services, alongside plastic injection molding, CNC milling, and EDM. They serve diverse markets including medical, automotive, and aerospace, with featured projects like laboratory tubes and microfluidic plates.

sales@eaglemold.cc+19377463331

Elite Precision Plastics

eliteprecisionplastics.com
Cincinnati, OH

Based in Cincinnati, OH, Elite Precision Plastics specializes in contract and private label plastic manufacturing. They provide American-made plastic products for healthcare institutions, pharmaceutical/biotech, and military/aerospace industries, ensuring precision quality and end-to-end capabilities.

info@eliteplasticsmanufacturing.com+18552916701

Genesis Medical Plastics

genesismedicalplastics.com
—

Genesis Medical Plastics specializes in converting implantable PEEK and other medical polymers into precision injection molded and machined components, stock shapes, and film. Serving the medical device industry, they support projects from prototype to full-scale production. The company is ISO 13485 and FDA registered.

inquiries@genesismedicalplastics.com+12812556848

HDA Technology

hdatechnology.com
Forest, VA

Based in Forest, VA, HDA Technology provides medical device product development and contract manufacturing services. They specialize in precision injection molding, cleanroom molding, overmolding, and insert molding for the medical device and life science industries.

web@hdatechnology.com+19492229935

Hi-Rel Plastics & Molding, Inc.

hirelplastics.com
Riverside, CA

Based in Riverside, CA, Hi-Rel Plastics & Molding, Inc. offers custom plastic injection and blow molding services. They are ISO 13485:2016 certified for medical devices and operate an ISO 7 (Class 10,000) clean room. With 40+ years experience, they provide prototyping and solutions for complex designs.

info@hirelplastics.com+19513540258

Plastic Molding Technology (PMT)

ht-medicaldevices.com
El Paso, TX

Based in El Paso, TX, Plastic Molding Technology (PMT) is a custom processor specializing in precision injection-molded parts. They have extensive experience manufacturing components for medical device companies, providing reliable and high-quality solutions.

info@ht-medicaldevices.com+13037688380

JDI Plastics

jdiplastics.com
Palatine, IL

Based in Palatine, IL, JDI Plastics provides high-quality, FDA-compliant medical injection molding services. The company specializes in high-tolerance molding for intricate medical devices, utilizing thermoplastics, elastomers, and biocompatible polymers. They focus on precision, reliability, and custom designs to meet the healthcare industry's specific demands.

sales@jdiplastics.com+18157595640

MOS Plastics

ksplastic.com
San Jose, CA

Based in San Jose, CA, MOS Plastics, a division of KS Group, specializes in diagnostic device and medical injection molding. They are a preferred supplier, providing critical components for the medical industry. The company is known for its expertise in high-quality, precision molding for demanding applications.

mbauer@ksplastic.com+15103518230

Majors Plastics, Inc

majorsplastics.com
—

Majors Plastics, Inc. specializes in custom injection molding, offering cleanroom molding compliant with ISO 14644 class 7 (Class 10,000). They provide hyper-clean components for medical and pharmaceutical suppliers, encompassing overmolding, secondary processing, and specialized cleanroom packaging. Their proven processes ensure particulate-free molded products and rigorous quality assurance.

majors@majorsplastics.com+14023311660

Matrix Plastic Products, LLC

matrixplastic.com
Wood Dale, IL

Based in Wood Dale, IL, Matrix Plastic Products, LLC specializes in high-precision plastic injection molding and moldmaking. They are ISO 9001 and ISO 13485 certified, utilizing GMPs and cleanroom capabilities. The company focuses on manufacturing critical plastic components and mold tooling with surgical precision for the medical device industry.

info@matrixplastic.com+16305956144

Meridian Products Corporation

meridianproductscorp.com
Dallas, TX

Based in Dallas, TX, Meridian Products Corporation provides plastic injection molding, insert molding, and overmolding services. The company produces complex and intricate parts for industries such as aerospace, automotive, electronics, and medical components. They utilize advanced techniques to meet client requirements and quality standards.

info@meridianproductscorp.com+19724847300

Metro Custom Plastics

metrocustomplastics.com
Dallas Fort Worth, TX

Based in Dallas Fort Worth, TX, Metro Custom Plastics provides comprehensive plastic injection molding services. They work with various thermoplastics, molding parts up to 5 pounds using 230-650 ton clamping forces. Capabilities include up to 64-cavity molds, reshoring, assembly, engineering, and drop shipping for production.

webleads@metrocustomplastics.com+18176405646

ASPM

mincogroup.com
—

ASPM specializes in plastic injection molding and manufacturing, offering comprehensive support from product design to mold maintenance and repair. Operating a robust 24-hour facility, the company serves diverse industries, including medical, aerospace, automotive, consumer electronics, and electric vehicles.

mincotool@mincogroup.com+19378907905

MRPC, LLC

mrpcorp.com
Butler, WI

Based in Butler, WI, MRPC is an FDA-registered and ISO 13485 certified contract manufacturer focused on medical devices. They specialize in custom plastic, liquid silicone rubber (LSR), and two-shot injection molding services, complemented by cleanroom assembly and comprehensive tooling solutions for the medical industry.

sales@mrpcorp.com+12627817122

Paramit

paramit.com
Morgan Hill, CA

Based in Morgan Hill, CA, Paramit is a contract manufacturer specializing in medical devices and life sciences. The company provides a range of manufacturing services including plastic injection molding, micro-molding, and cleanroom assembly for complex systems and instruments, ensuring high-quality production.

hr@paramit.com+14087825600

Polymation

polymation.com
Thousand Oaks, CA

Based in Thousand Oaks, CA, Polymation provides injection-molded plastics, specializing in designing, building, and mass producing high-quality plastic components. They serve a range of industries, including medical, dental, and commercial. The company focuses on precision parts through close collaboration and in-person consultations with clients and engineers.

mark@polymation.com+18058442921

Precision Molded Plastics, Inc.

precisionmoldedplastics.com
Upland, CA

Based in Upland, CA, Precision Molded Plastics, Inc. is a vertically integrated plastic injection molding company. They provide custom mold and tooling, part manufacturing, and various value-added services. With over 45 years of experience, they serve diverse sectors including medical, aerospace, food and beverage, and construction.

info@precisionmoldedplastics.com+19099819662

Quality Plastics

qualityplasticsllc.com
Fredericksburg, OH

Based in Fredericksburg, OH, Quality Plastics specializes in custom injection molding, serving the medical device manufacturing industry. They offer comprehensive solutions from engineering and prototyping to assembly and packaging. The company provides clean room capabilities for critical component production.

sales@qualityplasticsllc.com+13306955920

RIM Manufacturing, LLC

reactioninjectionmolding.com
Weatherford, TX

Based in Weatherford, TX, RIM Manufacturing, LLC specializes in custom Reaction Injection Molding (RIM) services. They provide comprehensive support from part design, mold manufacturing, and production to secondary processing and assembly. Certified to ISO 9001:2015 and ISO 13485:2016, they are equipped for high-quality manufacturing, including medical devices.

contact@rimmfg.com+18175996521

RenyMed

renymed.com
Baldwin Park, CA

RenyMed, a full-service injection molder based in Baldwin Park, CA, specializes in the Medical Device industry. The company provides creative technical solutions and high-level quality engineering expertise for medical plastics processing, offering streamlined rapid prototyping, production, and validation processes.

info@renymed.com+16263843864

RMC Plastics

rmcplastics.com
Houston, TX

Based in Houston, TX, RMC Plastics provides custom injection molding services for precision plastic and rubber parts. With over 50 years in operation, they serve nationwide clients, including the Medical, Oil & Gas, and Consumer Products industries. They guide material selection and tooling options.

customerservice@rmcplastics.com+12814475727

Seaway Plastics

seawayplastics.com
Port Richey, FL

Based in Port Richey, FL, Seaway Plastics provides ISO 13485-certified injection molding services. The company specializes in manufacturing solutions for medical devices, utilizing controlled manufacturing environments to meet industry standards.

rkretzmer@seawayplastics.com+17278453235

SIMTEC Silicone Parts

simtec-silicone.com
Miramar, FL

Based in Miramar, FL, SIMTEC Silicone Parts specializes in medical and healthcare LSR injection molding. They utilize advanced, highly automated manufacturing with ISO 13485 certification and a class 8 clean room. The company produces high precision silicone components, including 2-shot and multi-shot parts.

info@simtec-silicone.com+19546564212

Springboard Manufacturing

springboardmfg.com
Kearney, NE

Based in Kearney, NE, Springboard Manufacturing offers ISO 13485:2016 certified custom medical injection molding and assembly services. They specialize in state-of-the-art plastic molding, including overmolding and insert molding. The company produces medical device components, such as for stents, implants, and sutures, utilizing diverse thermoplastic materials.

help@springboardmfg.com+19168530717

SRC Medical

srcmedical.com
Hanover, MA

Based in Hanover, MA, SRC Medical is an ISO 13485:2016 certified manufacturer specializing in medical injection molded products. Founded in 1972, the company provides high-quality, precision molding solutions for the medical industry.

info@srcmedical.com+17818269100

Pleasant Precision, Inc.

teamppi.com
Kenton, OH

Based in Kenton, OH, Pleasant Precision, Inc. is a contract manufacturer offering injection molding, mold making, and extrusion. The company operates a Class 100,000 cleanroom and uses electric injection molding machines to produce high-quality parts. They hold IATF 16949:2016 certification, assisting clients from product design to finished goods.

dbray@teamppi.com+18008603974

PTI Engineered Plastics, Inc.

teampti.com
Macomb, MI

Based in Macomb, MI, PTI Engineered Plastics, Inc. offers ISO 13485:2016 certified and FDA registered plastic injection molding services for medical devices. The company provides medical device manufacturers advanced product development, leveraging over 40 years of experience for complex parts in applications like endoscopy, cardiovascular, and drug delivery.

info@teampti.com+15862635100

TechNH

technh.com
Merrimack, NH

Based in Merrimack, NH, TechNH specializes in custom plastic injection molding, with primary expertise in medical devices. The company supports healthcare advancements through precision engineering and superior quality, leveraging over four decades of experience manufacturing components for medical technology companies.

sales@technh.com+16034244404

Trademark Plastics

trademarkplastics.com
Riverside, CA

Based in Riverside, CA, Trademark Plastics provides full-service custom plastic injection molding as a vertically integrated contract manufacturer for the healthcare industry. Featuring Class 8 cleanrooms and 51 injection molding machines, they deliver high-precision prototypes and turnkey solutions. The company is ISO 9001 and 13485 certified.

cs@trademarkplastics.com+19512311480

Utah Medical Products, Inc.

utahmed.com
—

Utah Medical Products, Inc. offers subcontract manufacturing and molding services for the medical device industry. With ISO 13485 certified and FDA Registered facilities in Utah, they specialize in silicone/liquid injection molding (LIM), thermoplastic injection molding, and insert/over-molding for electronic and plastic medical components.

info@utahmed.com+18005334984

Valencia Plastics, Inc.

valenciaplastics.com
Valencia, CA

Based in Valencia, CA, Valencia Plastics, Inc. specializes in plastic injection molding and custom mold creation. For nearly two decades, the company has served the medical industry by providing injection-molded components and products. They also offer blow molding services and maintain ISO 9001-2015 and cGMP certifications.

info@valenciaplastics.com+18445742040

Vantage Medtech

vantagemedtech.com
Lyndhurst, NJ

Based in Lyndhurst, NJ, Vantage Medtech is an FDA registered and ISO13485 certified medical device contract manufacturer. They offer integrated solutions for small to large scale builds, with accessible on-site engineering support. Capabilities include production scalability, supply chain management, and global distribution for high-quality medical device manufacturing.

sales@vantagemedtech.com+19133855700

World Class Plastics Inc.

worldclassplastics.com
Russells Point, OH

Based in Russells Point, OH, World Class Plastics Inc. offers custom injection molding services. They engineer high-quality plastic parts for medical supplies, equipment, and dental retainers. Capabilities include tight tolerances, cavity pressure control, and molding diverse materials like Acrylic, ABS, Nylon, and Polycarbonate with clamping forces from 50 to 750 metric tons.

sales@worldclassplastics.com+19378434927

WP Manufacturing

wpmfg.com
Longmont, CO

Based in Longmont, CO, WP Manufacturing is an ISO 13485:2016 certified plastic injection molding company. They provide comprehensive contract manufacturing services, including custom injection molding, mold fabrication, and component assembly. WP Manufacturing offers full-service support from prototype to production, ensuring quality and traceability.

info@wpmfg.com+13037721325

Saint-Gobain Medical

medical.saint-gobain.com
—

Saint-Gobain Medical designs, develops, and manufactures custom medical components and engineered systems. The company provides a range of solutions for medical devices, specializing in high-performance materials and complex geometries. They serve the broader medical industry with their manufacturing capabilities, focusing on innovative and reliable components.

csirt@saint-gobain.com

Molded Devices, Inc.

moldeddevices.com
Tempe, AZ

Based in Tempe, AZ, Molded Devices, Inc. provides over 50 years of expertise in plastic injection molding and medical device contract manufacturing. They offer cleanroom manufacturing, medical assembly, insert and overmolding, dip molding, blow molding, and tube extrusion. The company supports medical product design and development, serving diverse industrial and healthcare OEM needs.

info@moldeddevices.com

Xcentric Mold

xcentricmold.com
Clinton Twp, MI

Based in Clinton Twp, MI, Xcentric Mold offers extensive expertise in serving the medical industry. The company specializes in producing high-quality injection molded parts and prototypes, ensuring precise solutions for various healthcare applications and project requirements.

sales@xcentricmold.com

AdvancTEK

advanctek.com
New Albany, OH

Based in New Albany, OH, AdvancTEK specializes in plastic molding solutions, including injection molding, reaction injection molding, and thermoforming. The company provides non-invasive medical products such as MRI and CT scanner housings, bins, and containers, serving a variety of industries prominently featuring the medical sector.

+16142895360

All Plastics

all-plastics.com
Kerrville, TX

Based in Kerrville, TX, All Plastics specializes in custom plastic scientific injection molding. The company serves the Pharmaceuticals and Medical markets, among others including Consumer and Industrial. All Plastics holds ISO 13485 certification, demonstrating its commitment to quality management systems for medical devices.

+19722392686

BMP Medical

bmpmedical.com
Sterling, MA

Based in Sterling, MA, BMP Medical offers ISO 13485 certified custom plastic injection molding for medical and diagnostic OEMs. They provide high-volume production with 19 machines and Class 8 cleanroom capabilities. The company manufactures various medical plastics, including vials, PCR kits, and biopharma packaging.

+18002533684

Comar

comar.com
—

Comar is a contract manufacturer specializing in plastic packaging and medical solutions. The company partners with clients to develop high-impact products for health and wellness applications, transforming concepts into reality. Comar leverages 75 years of experience in manufacturing a range of custom and stock solutions.

+18009626627

DEIMLING/jeliho Plastics

deimling-jeliho.com
Amelia, OH

Based in Amelia, OH, DEIMLING/jeliho Plastics is a custom thermoplastics injection molder and contract manufacturer established in 1976. The company specializes in highly engineered molded components and assemblies. They actively produce components for the medical device and equipment markets, supporting the healthcare system.

+15138316414

DEM Medical

dem-mfg.com
Newbury, OH

Based in Newbury, OH, DEM Medical is an FDA-registered manufacturer of medical devices. They provide end-to-end support from concept creation and rapid prototyping to medium-volume production, including custom injection molded components. The company ensures high quality standards with a robust QMS for consistent results.

+14405647160

Distinctive Plastics, Inc.

dpi-tech.com
Vista, CA

Based in Vista, CA, Distinctive Plastics, Inc. (DPI) specializes in technical injection molding services for medical device manufacturers. The company utilizes Class 8 Clean Room workstations, equipped with HEPA filtered, positive airflow, for precision plastic molding. DPI is ISO 13485:2016 certified and FDA Registered.

+17605999100

Extreme Molding

extrememolding.com
Menands, NY

Based in Menands, NY, Extreme Molding specializes in silicone injection molding for medical components and life science products. The company holds ISO 9001:2015 and ISO 13485-2016 certifications, and is QRS-compliant. They offer full-service production, including assembly and packaging, for healthcare and high-end consumer product markets.

+15183269319

Ferriot Inc.

ferriot.com
Akron, OH

Based in Akron, OH, Ferriot Inc. is a full-service contract manufacturer offering custom injection molding services. With nearly 100 years of experience, the company provides integrated solutions from engineering to final assembly. They specialize in manufacturing diverse products, emphasizing quality and capabilities for life-related applications.

+13307863000

Forum

forumcm.com
—

Forum specializes in medical injection molding, providing high-quality components for Class I, II(b), and III devices. With over 30 years of experience, they offer ISO 13485:2016 certified services, including Class 7 cleanroom molding and thin-wall capabilities. They work with various medical-grade materials, supporting surgical and medical instrument components.

+12037540777

Gilero

gilero.com
Durham, NC

Based in Durham, NC, Gilero provides precise plastic injection molding solutions for medical devices. The company offers tailored product development services, guiding clients from concept through commercialization. Gilero ensures high-quality, compliant healthcare products, adhering to current Good Manufacturing Practices and expanding manufacturing in Greensboro, USA.

+19195958220

Granite State Plastics

granitestateplastics.com
Hudson, NH

Based in Hudson, NH, Granite State Plastics specializes in medical plastic injection molding and assembly. The company holds ISO 13485 certification and utilizes class 7 and 8 cleanrooms. They focus on the healthcare marketplace, providing solutions for surgical instruments, drug delivery, diagnostic applications, and pain management wearables.

+16035957790

J&O Plastics

jandoplastics.com
Rittman, OH

Based in Rittman, OH, J&O Plastics provides custom injection molding services, specializing in clear plastic products for medical, consumer, and industrial applications. They mold PET, acrylic, polypropylene, SAN, crystal styrene, and PVC, offering additional services like assembly and retail direct shipping.

+13309273169

JG Plastics Group LLC

jgplastics.com
Costa Mesa, CA

Based in Costa Mesa, CA, JG Plastics Group LLC specializes in precision injection molded parts and tooling for medical device companies. Leveraging over 40 years of medical molding experience and scientific molding principles, they operate a 36,000 sq. ft. manufacturing facility to produce high-tolerance components.

+17147514266

J&L Plastic Molding

jlmolding.com
Wallingford, CT

J&L Plastic Molding, based in Wallingford, CT, specializes in medical device molding. The company is ISO 13485:2016 certified, offering comprehensive tooling and molding solutions. They deliver high-quality, compliant plastic molding services tailored specifically for the medical device industry, ensuring precision for critical applications.

+12032656237

Kaysun Corporation

kaysun.com
Manitowoc, WI

Based in Manitowoc, WI, Kaysun Corporation offers full-service custom medical injection molding. They provide engineered excellence for critical-use devices, from part and tooling design to material selection and process control. Kaysun holds MedAccred Plastics accreditation, delivering consistent value and quality for medical OEMs.

+19206865800

MedBio LLC

medbiollc.com
Grand Rapids, MI

MedBio LLC, headquartered in Grand Rapids, MI, specializes in medical injection molding for biotech products. They utilize ISO Class 7 and 8 cleanrooms, including micro-molding presses, and scientific molding practices. With over 100 molding machines, ranging from 17 to 440 tons, MedBio provides comprehensive manufacturing capabilities for diverse medical projects.

+16162450214

Natech Plastics

natechplastics.com
Ronkonkoma, NY

Based in Ronkonkoma, NY, Natech Plastics provides integrated injection molding and contract manufacturing solutions specifically for medical diagnostics and life sciences. They specialize in engineering and producing complex consumables and instruments, supporting startups with design and manufacturing services for their devices.

+16315803506

Plastics Plus Technology, Inc.

plasticsplus.com
—

Plastics Plus Technology, Inc. is a US-based, woman-owned contract manufacturer specializing in medical injection molding services. They produce devices and components, including fluid control, valves, and adapters. The company is ISO 13485:2016 certified, FDA Registered, and adheres to GMPs, offering full assembly, packaging, and process validation.

+19097470555

Plastikon Industries, Inc.

plastikon.com
Hayward, CA

Based in Hayward, CA, Plastikon Industries provides plastic injection molding and blow/fill/seal (BFS) manufacturing for the healthcare and pharmaceutical sectors. Capabilities include prototyping, mold design, and engineering, supported by Class 100k and 10k clean room environments. They also offer secondary services like part decoration and assembly.

+18885389374

Plastikos Inc

plastikoserie.com
—

Plastikos Inc. provides precision medical injection molding services, producing critical components for medical devices. The company is certified to ISO 13485, ISO 9001, and ISO 14001 standards, ensuring high quality and regulatory compliance for its specialized manufacturing.

+13503127283

Plastic Molded Concepts, Inc.

pmcplastics.com
Eagle, WI

Based in Eagle, WI, Plastic Molded Concepts, Inc. provides medical plastic injection molding services. They produce components for end-use medical devices and complex assemblies, selecting engineered plastic resins for specific physical properties. The company focuses on biocompatibility and compliance for the medical manufacturing industry.

+12625945050

Progressive Molding Technologies, Inc.

promoldtech.com
Medina, OH

Based in Medina, OH, Progressive Molding Technologies, Inc. provides high-precision plastic injection molding services. Capabilities include product development, prototyping, tooling, and manufacturing for diverse industries. The company specializes in delivering innovative, cost-effective injection molding solutions for applications like advanced medical devices, adhering to ISO 9001:2015 quality standards.

+13302207030

The Rodon Group

rodongroup.com
Hatfield, PA

Based in Hatfield, PA, The Rodon Group specializes in plastic injection molding solutions. They provide comprehensive services tailored for the medical and pharmaceutical industries, ensuring high-quality, precision-molded plastic components. Their expertise supports vital applications in healthcare with advanced manufacturing capabilities.

+18005238792

Sanbor Medical

sanbormedical.com
Allentown, PA

Based in Allentown, PA, Sanbor Medical is a medical device contract manufacturer. The company specializes in medical injection molding, cleanroom manufacturing, and comprehensive assembly and packaging services for medical disposables. With over 30 years of experience, they provide end-to-end solutions, including design and engineering support for the medical industry.

+16105308500

Southwest Plastics

southwestplastics.com
Glendora, CA

Based in Glendora, CA, Southwest Plastics provides precision plastic injection molding, thermoset compression, transfer, and compression molding services. They manufacture custom plastic parts in the USA, offering capabilities like CNC machining, tooling, assembly, and testing for durable, high-performance components.

+16269636919

Spectrum Plastics Group

spectrumplastics.com
—

Spectrum Plastics Group specializes in custom plastic injection molding for diverse medical applications including orthopedic, dental, and gastrointestinal devices. They handle complex, tight-tolerance projects, producing premium, high-quality components and fully assembled medical devices using highly engineered performance medical plastics.

+14045648560

Thogus

thogus.com
Avon Lake, OH

Based in Avon Lake, Ohio, Thogus is an established, family-owned custom plastic injection molder and contract manufacturer founded in 1950. The company provides precision injection molding for critical plastic components and high-performance applications, offering mid- to high-volume manufacturing services. Capabilities include engineering support, tooling, secondary operations, and expertise in various resins, including for radiation processing.

+18669338850

Universal Plastics

universalplastics.com
Holyoke, MA

Universal Plastics provides custom plastic manufacturing services, specializing in injection molding, including gas assist and structural foam, from small to large tonnage presses. The company serves the medical, laboratory & diagnostic, aerospace, transportation, and general industrial markets, offering in-house painting, secondary operations, and assembly services.

+14135924791

Westec Plastics

westecplastics.com
Livermore, CA

Based in Livermore, CA, Westec Plastics is an ISO 13485:2016 certified plastic injection molding organization founded in 1969. They specialize in precision injection molding, mold building, clean room operations, and secondary services. Westec serves medical, aerospace, defense, consumer products, and electronics industries.

+19254543400

Freudenberg Medical

freudenbergmedical.com
Carpinteria, CA

Freudenberg Medical is a contract design and manufacturing organization (CDMO) specializing in medical components and devices. The company offers vertically integrated capabilities, including precision molding and and extrusion. With deep materials expertise in thermoplastics and silicones, they support medical device and pharmaceutical innovations from ideation to full-scale production.

No contact on file

Qure Medical

injection-molded-plastics.net
Pepper Pike, OH

Based in Pepper Pike, OH, Qure Medical specializes in providing precision injection molded plastic products. The company serves the medical and pharmaceutical industries with high-quality manufacturing solutions for critical applications.

No contact on file

Medical Components of America

medicalcompofamerica.com
Seguin, TX

Based in Seguin, TX, Medical Components of America specializes in manufacturing small, precision medical parts. The company focuses on cost-effective production while maintaining the highest quality standards. Utilizing computer-integrated manufacturing and plastics technology, they optimize processes for efficient product realization in the medical device sector.

No contact on file

Thunderbird Molding

thunderbird-molding.com
Shelbyville, IN

Thunderbird Molding provides medical custom plastic injection molding and assemblies for OEMs. The company operates a Class 7, ISO-compliant, FDA-approved clean room, ensuring ultra-clean, contaminant-free medical parts. They offer engineering support, design assistance, and on-site assembly within controlled environments, meeting stringent industry regulations and patient safety standards.

No contact on file

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How to Choose a Company

  • Validate Cleanroom Certifications and Usage: Beyond a simple ISO 13485 certification, verify the molder's cleanroom classification (e.g., ISO Class 7 or 8 per ISO 14644-1) and understand how they maintain it, including air changes per hour, gowning procedures, and routine particulate monitoring. Crucially, confirm the specific product lines you require will be molded within that certified environment, not just secondary operations.
  • Assess Validation Protocol Expertise: Insist on detailed evidence of their experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for medical devices. A red flag is a supplier who downplays the rigor or cost of these protocols, or one who cannot provide examples of robust validation master plans and associated documentation packages for similar medical components.
  • Scrutinize Material Biocompatibility and Traceability: For components intended for body contact or fluid path, demand documented proof of material USP Class VI compliance or other relevant biocompatibility standards, directly from the resin manufacturer. Ensure their material traceability system can link every batch of resin to specific production lots and ultimately to your finished devices.
  • Demand Evidence of Process Capability (Cpk): Do not settle for anecdotal assurances of quality. Request historical Process Capability Index (Cpk) data for critical dimensions on similar components they mold. For high-volume, critical-to-function parts, aim for Cpk values of 1.33 or higher on key features, and understand their methodology for maintaining and monitoring this over time.
  • Beware of Inadequate Tooling and Gate Vestige Management: A common pitfall is underestimating the upfront investment in high-quality, hardened steel tooling designed for millions of cycles and precise flash mitigation. Challenge suppliers on their approach to gate vestiges and de-gating, especially for components requiring automated secondary processing or where manual removal could introduce particulate or damage a sealing surface.

Supplier Types at a Glance

TypeBest ForTypical MOQ
Micro-Molding SpecialistExtremely small, intricate components (e.g., catheter tips, endoscopic device parts) requiring sub-millimeter features, ultra-tight tolerances, and specialized materials like PEEK or bioresorbables. Often involves insert molding.50,000 - 5,000,000+
Cleanroom & Assembly CMTCompanies needing injection molding within ISO Class 7/8 environments, often combined with automated or manual assembly, secondary operations (e.g., ultrasonic welding, pad printing), and integrated packaging solutions for finished medical devices.10,000 - 1,000,000+
High-Volume OEM PartnerEnterprise-level projects requiring multi-cavity tooling, dedicated work cells, global supply chain management, and often high-cavitation hot runner systems for disposables, diagnostic consumables, or drug delivery components. Focus on cost-efficiency at scale.100,000 - 10,000,000+
Prototype & Niche MolderStartups or R&D teams needing low-volume, quick-turn prototypes, bridge tooling, or specialized expertise in a particular material (e.g., liquid silicone rubber, ceramic injection molding) before scaling.100 - 10,000

Frequently Asked Questions

How do I ensure a supplier's cleanroom meets our specific product needs, beyond just ISO certification?

Beyond the ISO 14644-1 classification (e.g., ISO Class 7 or 8), a critical step is to understand the operational controls within that cleanroom. Ask about their particulate monitoring protocols, air change rates, positive pressure differentials, gowning procedures, and ingress/egress controls. Importantly, verify that your specific molding operations will occur within the certified area, not just post-molding handling or packaging, and request a tour of the facility to observe these practices firsthand.

What validation protocols (IQ/OQ/PQ) should I expect from a medical injection molding supplier, and how should they be documented?

For medical devices, expect robust Installation Qualification (IQ) to verify equipment installation; Operational Qualification (OQ) to confirm the process operates consistently within defined parameters; and Performance Qualification (PQ) to demonstrate that the process consistently produces conforming product under actual or simulated production conditions. Documentation should include a detailed Validation Master Plan, written protocols, executed reports with raw data, and a final summary report signed off by quality and engineering. Deviations must be addressed and documented.

What are the key considerations for material biocompatibility when selecting resins for medical components?

Material biocompatibility is paramount for patient safety. Primarily, you'll need to specify materials that meet USP Class VI standards or relevant ISO 10993 classifications, depending on the duration and type of body contact. Beyond certification, consider leachables and extractables profiles, sterilizability compatibility (e.g., gamma, ETO, autoclave), and any potential degradation products. Always request material certifications from the molder, tracing back to the resin manufacturer's specific lot data.

Beyond cost, what are the biggest risks in selecting a medical injection molding partner for high-volume, critical components?

The primary risks often revolve around regulatory non-compliance, inability to maintain consistent process capability index (Cpk), and inadequate supply chain control. A significant gotcha is a supplier whose tooling strategy prioritizes low upfront cost over long-term reliability, leading to premature wear, increased flash mitigation issues, and inconsistent gate vestiges that impact downstream assembly. Additionally, a lack of robust change control procedures for molds, materials, or processes can introduce compliance risks.

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