Precision Medical Plastic Molds: Engineering Excellence for Critical Healthcare Applications
Good quality medical plastic molds are designed and manufactured to meet the strict ISO 13485 and FDA standards required by the medical industry. These precision tools produce components for life-saving devices including surgical instruments, drug delivery systems, and implantable prosthetics.
DERCO's Advanced Medical Mold Manufacturing Process
Medical-Grade Material Selection
Our engineers specify USP Class VI, ISO 10993-certified materials including:
• PEEK (for sterilizable components)
• PC-ISO (transparent surgical housings)
• PEI (autoclavable instrument handles)
All resins undergo batch-level biocompatibility testing in our ISO Class 7 cleanroom facility.Patient-Safe Design Engineering
Our DFM (Design for Manufacturing) approach incorporates:Undercut-free parting lines to prevent bacterial harborage
Uniform wall thicknesses for consistent sterilization
Textured surfaces meeting FDA 21 CFR Part 820 requirements
Controlled Environment Production
DERCO's vertically integrated manufacturing ensures:
Class 100,000 cleanroom injection molding
Validated mold steel polishing to Ra 0.05μm
In-process particulate monitoringComprehensive Validation Protocols
Every medical plastic mold undergoes:
• 3D scanned dimensional verification (±5μm tolerance)
• Moldflow analysis for perfect filling balance
• Ethylene oxide sterilization compatibility testing
Why Global Medical OEMs Trust DERCO
Turnkey Solutions: From mold design to packaged sterile components
Regulatory Expertise: Full documentation for FDA/CE/MDR submissions
Production Scalability: Validated family molds for high-volume manufacturing
Recent Project Highlight
Developed a multi-cavity mold for COVID-19 test kit components featuring:
0.005mm positional accuracy for microfluidic channels
Automatic degating for aseptic production
48-hour rapid tooling turnaround
Quality Assurance at Every Stage
DERCO’s quality team implements:
• PPAP documentation packages
• Cavity-to-cavity statistical process control
• Lot traceability via laser-marked DMR numbers
Contact DERCO Today
For ISO 13485-compliant medical plastic molds that combine German engineering precision with cost-effective Asian manufacturing. Our team stands ready to assist with your most challenging medical device projects.
Here are some key factors that contribute to the quality of medical plastic molds:
Material selection: Medical plastic molds require the use of medical-grade materials that are biocompatible and meet strict safety standards. These materials must be free of contaminants and impurities that could pose a risk to patient health.
Design: The mold design must be optimized for the specific application and part geometry. The design should take into account factors such as mold flow, draft angles, and parting lines.
Manufacturing process: The manufacturing process must follow strict protocols to ensure the molds are produced in a clean and controlled environment. Processes such as injection molding must be performed under cleanroom conditions to prevent contamination.
Quality control: Quality control is critical to ensure that the molds meet the required specifications. The molds must be inspected for surface finish, dimensional accuracy, and material properties.
Validation: Medical plastic molds must be validated to ensure they meet the required standards. This includes testing for biocompatibility, sterility, and other safety parameters. Good quality medical plastic molds require expertise in design, manufacturing, quality control, and validation. It is essential to work with experienced professionals who have a deep understanding of the unique requirements of the medical industry to ensure the highest level of quality and safety.DERCO provide high-standard injection mold customization service for customer worldwide, and a full set of injection mold services including mold making, mass production, package, delivery are all available.