Medical devices demand precision, consistency, and safety. From diagnostic tools to surgical components, every part must meet tight tolerances and comply with strict regulatory guidelines. Medical plastic standards define the benchmark for safety and performance, and at PMC, we meet those benchmarks with advanced precision injection molding capabilities tailored to the medical field.
Understanding Medical Plastic Standards
The healthcare industry requires materials and processes that ensure safety for both patients and practitioners. These standards are not just recommended—they are essential.
Medical plastic components must meet strict requirements for:
- Biocompatibility – Materials must be safe for contact with human tissue and fluids.
- Sterilization compatibility – Components must withstand autoclaving, gamma radiation, or ethylene oxide sterilization without degrading.
- Traceability and documentation – Every batch must be traceable to ensure consistent quality and regulatory compliance.
- Tight tolerances – Precision is critical in parts used in devices like syringes, diagnostic cartridges, and implants.
To remain compliant, precision injection molding must be paired with strong process control and thorough documentation at every stage.
How PMC Delivers on Precision and Compliance
At PMC, our approach to medical plastic injection molding is defined by consistency, precision, and deep industry expertise. We’re equipped to handle everything from pilot runs to full-scale production for FDA-regulated and ISO-certified products.
1. Tight Tolerance Capabilities
We understand that a deviation of even a few microns can render a medical device unusable. Our equipment and processes are designed to meet exact specifications with minimal variance, even in high-volume production.
- High-precision tooling
- Real-time monitoring during production
- Statistical process control (SPC) to ensure repeatability
2. Material Expertise for Medical Applications
We work with a range of medical-grade resins including PEEK, PEI (Ultem™), PPSU, PC, and others that comply with USP Class VI and ISO 10993 standards for biocompatibility.
- Selection guidance based on sterilization method
- Compatibility with chemical exposure and long-term durability
- Sourcing from FDA-approved material suppliers
3. Clean Manufacturing Practices
Medical-grade parts must be produced in an environment that reduces contamination risk. While PMC is not a cleanroom manufacturer, we follow strict clean manufacturing protocols, including:
- Dedicated molding areas for medical parts
- Rigorous equipment maintenance and cleanliness
- Employee training in medical handling procedures
4. Advanced Quality Planning & Documentation
PMC integrates Advanced Quality Planning (AQP) to ensure every step of the molding process is documented and verified before full production begins.
- First article inspection
- Validation and process qualification (IQ/OQ/PQ)
- Full lot traceability
- Certificates of compliance (CoCs)
Medical Applications We Serve
PMC supports a wide range of applications in the medical sector with precision injection molding, including:
- Surgical instruments and tool components
- Diagnostic device housings and inserts
- Fluid management components
- Drug delivery systems
- Implantable device components (short-term contact)
No matter how small or complex the component, we help bring critical medical devices to market with high precision, quality, and consistency.
Why Choose PMC for Medical Injection Molding?
When it comes to meeting medical plastic standards, PMC offers more than technical capability—we deliver peace of mind. Our team ensures every part meets your exact specifications and complies with all regulatory and industry standards.
Why Work with PMC?
- Deep expertise in medical-grade material selection
- Precision molding capabilities for micro and macro components
- Advanced quality control and traceability systems
- Commitment to customer communication and on-time delivery
Contact PMC for Your Medical Plastic Molding Needs
Your medical components deserve the highest standards of quality and performance. With PMC, you can trust our experience in precision injection molding and our unwavering commitment to medical plastic standards.
Contact PMC today to discuss your next medical project or request a quote for compliant, high-precision molding solutions.
Frequently Asked Questions (FAQ’s)
What types of plastics are used in medical injection molding?
Common materials include PEEK, PPSU, polycarbonate, PEI (Ultem™), and polypropylene. These meet FDA and ISO standards for biocompatibility and sterilization compatibility.
How does PMC ensure compliance with medical industry regulations?
We follow strict documentation protocols, advanced quality planning (AQP), and process validation procedures to meet FDA, ISO, and customer-specific standards.
Can PMC help with selecting the right resin for a medical application?
Yes. Our experts will recommend the best medical-grade resin based on your product’s required strength, sterilization method, and biocompatibility needs.
What tolerances can PMC hold for medical parts?
PMC specializes in tight-tolerance molding and can hold tolerances within a few microns, depending on part geometry and material.
Does PMC produce components for cleanroom assembly?
While we don’t operate a certified cleanroom, our clean manufacturing protocols meet the requirements of many medical OEMs. Contact us to discuss your specific needs.