Medical Grade Plastic Parts Manufacturing | FDA-Compliant Components

Medical grade plastics include materials that meet FDA, USP Class VI, and ISO 10993 biocompatibility standards. Common medical-grade resins include polycarbonate (PC), polypropylene (PP), polyethylene (PE), PEEK, polysulfone (PSU), liquid silicone rubber (LSR), and certain grades of ABS and nylon. These materials are specifically manufactured with controlled additives, documented purity, and consistent lot-to-lot performance. At Evok Polymers, we work with certified medical-grade material suppliers and provide complete material traceability documentation including resin certifications, lot numbers, and biocompatibility test reports for every production run.

Yes, medical grade plastics are specifically formulated and tested to be safe for healthcare applications. They undergo rigorous biocompatibility testing per ISO 10993 standards to ensure they don't cause adverse biological responses such as cytotoxicity, sensitization, or irritation. Medical grade plastics are manufactured in controlled environments with documented processes, contain no harmful additives or contaminants, and maintain consistent chemical composition. Safety is verified through material certifications, biological testing, and compliance with FDA regulations. Our manufacturing processes include complete lot traceability and quality documentation to ensure every component meets medical safety standards.

Medical grade PVC (polyvinyl chloride) is a specially formulated version of PVC that meets stringent healthcare standards for biocompatibility and safety. It's commonly used in medical tubing, blood bags, IV sets, and other fluid handling applications due to its flexibility, clarity, and chemical resistance. Medical grade PVC is manufactured without harmful plasticizers like DEHP in many applications, uses USP Class VI certified materials, and undergoes rigorous testing for extractables and leachables. The material provides excellent sterilization compatibility with gamma, EtO, and steam methods. We help medical device manufacturers select the appropriate grade of medical PVC based on specific application requirements and regulatory pathways.

Medical plastics are polymer materials specifically designed and certified for use in healthcare applications including medical devices, diagnostic equipment, pharmaceutical packaging, and surgical instruments. These materials must meet stringent regulatory requirements including FDA approval, USP biocompatibility classification, and ISO 10993 testing. Medical plastics offer advantages such as sterilization compatibility, chemical resistance, biocompatibility, dimensional stability, and cost-effectiveness compared to traditional materials. They're used in everything from implantable devices to external diagnostic equipment. Evok Polymers specializes in injection molding medical plastics with complete documentation, quality control, and regulatory support to ensure compliance throughout the product lifecycle.

FDA-approved plastics for medical use include polypropylene (PP), polyethylene (PE), polycarbonate (PC), PEEK, polysulfone, silicones, and certain grades of ABS and nylon. However, 'FDA approved' is a nuanced term – the FDA doesn't explicitly approve materials but rather evaluates them as part of complete device submissions. Materials must comply with FDA regulations (21 CFR for food contact, USP Class VI for biocompatibility) and be appropriate for their intended use. We help navigate material selection by reviewing FDA guidance documents, selecting materials with established safe use history, providing material master files when available, and ensuring complete documentation including biocompatibility testing and extractables/leachables studies for your specific application.

Medical device prototype development typically takes 2-4 weeks depending on part complexity, material availability, and testing requirements. Our rapid prototype process includes design review for manufacturability and regulatory compliance, selection of appropriate medical-grade materials with certifications, fabrication using production-intent processes when possible, and dimensional verification with documentation. For medical applications, we recommend allowing additional time for biocompatibility sample preparation, sterilization compatibility testing, and any required third-party testing. We work closely with your development timeline to provide prototypes that support design validation and regulatory submissions while minimizing delays.

For medical parts production, we provide comprehensive documentation to support your quality management system and regulatory requirements. This includes First Article Inspection Reports with full dimensional analysis and Cp/Cpk data, Certificate of Compliance for each production lot, material certifications with resin lot numbers and biocompatibility test results, process validation documentation including IQ/OQ/PQ protocols, statistical process control charts and trending data, change control documentation for any process modifications, and archived samples with complete traceability. All documentation follows FDA Quality System Regulations (21 CFR 820) and ISO 13485 standards to support your regulatory submissions and audit requirements.

Yes, we provide comprehensive manufacturing documentation to support your FDA submissions including 510(k), PMA, or De Novo applications. Our support includes detailed manufacturing process descriptions, material selection justification with biocompatibility data, design validation and verification test results, process validation protocols and reports, risk analysis documentation related to manufacturing, and supplier quality agreements and certifications. While we don't serve as your regulatory consultant, our 25 years of experience working with medical device manufacturers means we understand what information FDA reviewers need. We work collaboratively with your regulatory team to ensure all manufacturing-related documentation is complete, accurate, and submission-ready.