Medical device manufacturers face strict regulatory requirements when selecting injection molding partners for their products. Finding suppliers who maintain proper documentation, quality controls, and certification standards creates additional challenges during the vendor selection process. These compliance requirements become even more complex when navigating international markets with varying regulatory frameworks.
Seaway Plastics delivers ISO 13485-certified injection molding services with controlled manufacturing environments designed specifically for medical device production. Our certification and ISO:9001 quality management systems support healthcare manufacturers throughout their product development cycles.
Read on to learn more about how certified molding partners can streamline your medical device manufacturing process.
List of Plastic Injection Molding Companies with an ISO 13485 Certification
Seaway Plastics – Brooksville & Port Richey, FL
Hi-Rel Plastics – Riverside, CA
Crescent Industries – New Freedom, PA
AdvanTech Plastics – Woodstock, IL
Matrix Plastic – Wood Dale, IL
New Berlin Plastics – New Berlin, WI
ISO 13485 Certified Plastic Injection Molders FAQ
Q: What is an ISO 13485 Certification?
A: ISO 13485 is a standard for quality management systems in the medical device industry. It establishes the requirements for a quality management system for organizations involved in the lifecycle of a medical device. This includes design, development, production, storage, distribution, and installation. The certification confirms that a manufacturer has implemented processes that consistently meet customer and regulatory requirements.
Q: Why is an ISO 13485 Certification Important?
A: The ISO 13485 certification demonstrates a commitment to medical device safety and quality. It ensures that a manufacturer adheres to best practices and regulatory requirements. This standard unifies processes within the medical device industry, ensuring a high level of security and quality. The certification also helps meet requirements from various international regulations, including those in the European Union.
Q: What is the difference between ISO 9001 and ISO 13485?
A: ISO 9001 is a general quality management standard applicable to any organization. ISO 13485 is specific to the medical device industry. While both standards focus on quality management, ISO 13485 includes additional requirements for medical devices. These requirements cover areas like risk management, traceability, and regulatory compliance specific to the healthcare sector.
Q: What processes does an ISO 13485 certified molder have in place?
A: An ISO 13485 certified molder implements several processes to ensure product quality and safety. They maintain end-to-end traceability for raw materials and finished products. The system includes robust risk management and validation processes to verify manufacturing standards. Regular audits and reviews of the quality management system ensure ongoing compliance with the standard.
Comparison of ISO 13485 Certified Plastic Injection Molders
| Company | In-House Tooling | ISO 13485 Certified? | Cleanroom Manufacturing? | FDA Registered? |
| Seaway Plastics | Yes | Yes | Yes | Yes |
| Hi-Rel Plastics | Yes | Yes | Yes | No |
| VEM | Yes | Yes | Yes | No |
| Crescent Industries | Yes | Yes | Yes | Yes |
| D&M Plastics | Yes | Yes | Yes | No |
| AdvanTech Plastics | Yes | Yes | Yes | No |
| BMP Medical | Yes | Yes | Yes | Yes |
| Central Plastics | Yes | Yes | Yes | No |
| Matrix Plastic | Yes | Yes | Yes | No |
| New Berlin Plastics | Yes | Yes | No | No |
#1. Seaway Plastics – Brooksville & Port Richey, FL
At Seaway Plastics, we’re a plastic injection molder with ISO 13485 certification. We deliver end-to-end manufacturing solutions for precision medical components, devices, and assemblies. We provide in-house tooling, DFM, and full assembly services from our five U.S. facilities. All of our manufacturing locations are ISO 13485 certified and registered with the FDA.
Our ISO Class 7 and 8 certified cleanrooms provide a controlled environment for manufacturing components for Class 1, 2, and 3 medical devices. These facilities prevent airborne contamination during the molding and assembly of sensitive products. Key applications include components for surgical robotics, diagnostic testing, and implant-delivery systems.
Complete process validation packages ensure all quality and regulatory requirements are met for every project. We work with a wide range of medical-grade thermoplastics and liquid silicone rubber to produce these components. This integrated approach provides OEMs with a single partner for managing complex supply chains. With the sister facilities Wright Engineered Plastics and the MME Group also holding ISO-13485 certifications and FDA registrations, Seaway Plastics can produce high-volume medical injection molding projects while maintaining fast turnaround times and premium quality.
#2. Hi-Rel Plastics – Riverside, CA
Hi-Rel Plastics & Molding operates custom plastic injection and blow molding services for medical, aerospace, and scientific industries. The company handles part evaluation, tool design, and prototyping using thermoplastic resins that include commodity plastics and engineering-grade materials. Manufacturing takes place within an ISO 7 (Class 10,000) cleanroom environment to prevent contamination during processing.
The facility produces high-precision components with tolerances reaching ± 0.001 inch. Hi-Rel Plastics processes diverse materials to meet the exacting requirements these industries demand. Production capabilities support applications that require strict quality control and dimensional accuracy.
#3. VEM Tooling – Clovis, CA
VEM Tooling manufactures medical devices through plastic injection molding within a Class 10,000/ISO 7 cleanroom facility. The Thailand-based manufacturer maintains ISO 13485:2016 and ISO 9001:2015 certifications for quality management systems. VEM handles molding, assembly, and packaging using automated robotics and quality control equipment.
The facility builds molds in-house using imported certified steel and standard components. Production processes include spare parts manufacturing and replacement component delivery with reduced lead times. VEM follows rigorous protocols that meet regulatory standards required for medical device production across all stages of development.
#4. Crescent Industries – New Freedom, PA
Crescent Industries is an injection molder that produces components for Class I, II, and III medical devices. The company provides in-house tooling and utilizes a scientific injection molding process to ensure part consistency. Its quality management system is ISO 13485:2016 certified, and the facility is registered with the FDA.
Manufacturing and assembly take place within certified ISO 7 and ISO 8 cleanrooms. Crescent Industries employs a full validation protocol that includes installation, operational, and performance qualifications. The organization also maintains complete material traceability for all medical components.
#5. D&M Plastics – Burlington, IL
D&M Plastics is a custom injection molder that manufactures tight-tolerance components for the medical industry. The company provides in-house tooling services, and its quality management system is certified to ISO 13485:2016 standards. It specializes in producing complex parts using a wide range of medical-grade resins.
The company performs medical molding and manufacturing in an ISO Class 8 cleanroom. D&M Plastics implements a full validation process that includes IQ, OQ, and PQ protocols. The organization also maintains complete lot traceability for all raw materials used in production.
#6. AdvanTech Plastics – Woodstock, IL
Advantech Plastics provides injection molding services for the medical and pharmaceutical packaging industries. The company uses scientific molding principles to ensure process control and part repeatability. It is an FDA-registered facility and holds an ISO 13485:2016 certification.
The company performs medical molding in an ISO Class 8 cleanroom. Advantech Plastics also offers a range of secondary services, including assembly, decorating, and custom packaging. A full quality validation process includes IQ, OQ, and PQ to meet regulatory requirements.
#7. BMP Medical – Sterling, MA
BMP Medical supports the medical device market with injection molding, in-house tooling, and assembly services. Its quality management system holds an ISO 13485:2016 certification, and the facility is registered with the FDA. The company primarily serves the medical, diagnostic, and life science sectors.
All medical manufacturing and assembly takes place within three dedicated Class 8 cleanrooms. Full IQ, OQ, and PQ validation protocols ensure that all products meet strict regulatory requirements. The company offers a range of secondary services, including sterile packaging and inventory management.
#8. Central Plastics – Tracy, CA
Central Plastics provides precision custom injection molding with presses ranging from 24 to 800 tons. The company handles advanced processes, including overmolding, insert molding, and MICRO precision molding. It also performs medical device assembly and molding within a Class 100,000 cleanroom.
All molding operations follow ISO 13485 procedures and use a plant-wide monitoring system to ensure part consistency. They specialize in processing a range of medical, food-grade, and engineering resins. An in-house tool room maintains all molds after production, and 24-hour operations accommodate high-volume delivery schedules.
#9. Matrix Plastic – Wood Dale, IL
Matrix Plastic Products specializes in precision injection molding for complex, tight-tolerance components. The company employs scientific molding principles and its team includes RJG Master Molder-certified technicians. Its quality management system is certified to the ISO 13485:2016 standard.
Medical molding and assembly take place within certified cleanrooms. The facility uses all-electric presses from 30 to 300 tons and incorporates robotics for process automation. Matrix Plastic Products offers full IQ, OQ, and PQ validation to meet regulatory and project requirements.
#10. New Berlin Plastics – New Berlin, WI
New Berlin Plastics manufactures components using press equipment from 4 to 1,400 tons to handle different part sizes and complexity requirements. The company applies scientific injection molding practices that create repeatable results through controlled processes.
Process engineers train at the Master Molder School in Traverse City, Michigan, to master scientific molding techniques and data interpretation skills. This foundational education supports continuous employee development programs throughout the facility.
ISO 13485 Plastic Injection Molding at Seaway Plastics
ISO 13485 certified plastic injection molding companies provide medical device manufacturers with compliant manufacturing partners who understand healthcare industry requirements. These certified suppliers maintain the quality systems and documentation necessary for successful medical device production across global markets.
At Seaway, we combine our ISO 13485 certification with technical expertise to deliver reliable manufacturing solutions for medical device clients. Our controlled processes and quality management approach ensure consistent results that meet regulatory standards. Click below for a quote and to learn more about our certified medical device injection molding capabilities.