Reliable Solutions for Medical Device Manufacturing
The medical device industry continues to evolve rapidly, with technological advancements driving increased demand for precision, customization, and biocompatibility in components.
As healthcare providers seek more effective diagnostic and treatment options, medical device manufacturers require manufacturing partners who understand the unique challenges of this highly regulated industry.
- ISO13485 certified manufacturing partners
- Quality management system per ISO 9001:2015/13485:2016/14001:2015
- DFM and product validation
- Real-time Process Tracking System
- One-stop service for manufacturing, finishing and logistics
Why Choose FECISION for Medical Manufacturing?
Medical Manufacturing Expertise
At FECISION, we understand the critical importance of precision and reliability in medical device manufacturing.
Our ISO 13485 certified facilities deliver high-quality medical components that meet the industry's stringent regulatory requirements.
Precision Medical Mold Tooling
Medical CNC Machining
Medical Injection Molding
Medical Parts & Mold Components
Medical-Grade Materials
Material selection is critical for medical device performance. We work with FDA-approved and USP Class VI certified materials to ensure biocompatibility and regulatory compliance.
★ Medical-Grade Plastics
USP Class VI and ISO 10993 compliant polymers including PEEK, PPSU, and medical-grade silicone
★ Biocompatible Metals
316L stainless steel, titanium, and other implantable-grade alloys
★ Sterilization-Compatible Materials
Materials designed to withstand gamma, EtO, and autoclave sterilization processes
★ Implantable Materials
Materials suitable for long-term implantation with proven biocompatibility
★ Antimicrobial Compounds
Specialized materials with inherent antimicrobial properties for infection control
| Â | Properties | Applications | Sterilization Methods |
| Medical-Grade LSR | Biocompatible, flexible, temperature resistant | Seals, gaskets, tubing connectors | Autoclave, Gamma, ETO |
| PEEK | High strength, chemical resistant, radiopaque | Implantable components, surgical instruments | Autoclave, Gamma, Steam |
| PPS (Ryton) | High temperature, chemical resistant | Autoclavable components, sterilization trays | Autoclave, Steam |
| PEI (Ultem) | High heat resistance, sterilizable, transparent | Medical housings, sterilization containers | Autoclave, Steam, ETO |
| PC (Polycarbonate) | Transparent, impact resistant, sterilizable | Fluid chambers, viewing windows | ETO, Gamma (limited) |
| PP (Polypropylene) | Chemical resistant, low cost, sterilizable | Disposable components, packaging | Autoclave, Gamma, ETO |
Medical-Grade Injection Molding Capabilities
At Fecision, we specialize in precision injection molding for the medical device industry, operating in ISO Class 7 and Class 8 cleanroom environments. Our medical molding capabilities are designed to meet the stringent requirements of FDA-regulated devices, ensuring biocompatibility, sterility, and complete traceability throughout the manufacturing process.
Our Medical Molding Expertise Includes:
- ISO 13485:2016 Certified Quality Management – Full compliance with medical device quality standards
- Cleanroom Manufacturing – ISO Class 7 (10,000) and Class 8 (100,000) environments
- LSR Silicone Molding – Medical-grade liquid silicone rubber for seals, gaskets, and components
- High-Temperature Engineering Plastics – PEEK, PPS, PEI (Ultem) for sterilization-resistant parts
- Tight Tolerance Precision – Dimensional accuracy to ±0.005mm for critical components
- Full Traceability – Lot tracking, material certificates, and comprehensive documentation
Medical Manufacturing from Prototype to Production
Fecision offers a highly efficient and simplified supply chain solution. Whether you’re in the stage of creating prototypes, moving on to test units, initiating mass-production, or dealing with subsequent phases, Fecision has got you covered.
Prototype
- For the purpose of validating your materials and designs, get prototypes that come as close as feasible to your final design.
Prototype
DVT
Production
EVT
PVT
- Comprehensive functionality testing on the prototype
- Identify any flaws or areas for improvement in the design
Applications in Medical Industry
Our precision manufacturing capabilities serve diverse medical applications:
Surgical Instruments
- Minimally invasive surgical tools
- Endoscopic device components
- Surgical stapling device parts
- Electrosurgical instrument components
- Robotic surgery system components
Diagnostic Equipment
- Medical imaging device housings
- Point-of-care testing device parts
- Laboratory diagnostic equipment parts
- Patient monitoring device components
- Medical sensor housings and fixtures
Implantable Devices
- Orthopedic implant components
- Cardiovascular device parts
- Neurological implant housings
- Drug delivery system components
- Dental implant components
Medical Wearables
- Wearable monitoring device housings
- Drug delivery device components
- Patient compliance monitoring systems
- Rehabilitation device components
- Remote patient monitoring systems
ISO 13485 Certification
Meeting the highest medical device quality management standards
FDA Compliance
Manufacturing processes aligned with FDA requirements
Clean Room Manufacturing
Class 8 clean room facilities for critical medical components
Quality Assurance for Medical Manufacturing
Quality is paramount in medical device manufacturing
Validation Processes
Verification of component performance under simulated conditions
Material Traceability
Complete documentation and traceability for all medical materials
First Article Inspection
Comprehensive verification of initial production parts
Biocompatibility Testing
Coordination with certified testing laboratories for material biocompatibility
Medical Manufacturing Case Studies
We developed precision components for a next-generation minimally invasive surgical instrument, meeting tight tolerances and biocompatibility requirements while reducing assembly complexity by 30%.
Our team manufactured critical components for a point-of-care diagnostic testing device, delivering parts with exceptional consistency and reliability for accurate test results.
FECISION produced high-precision components for an implantable medical device, utilizing biocompatible materials and clean room manufacturing to ensure patient safety and device longevity.
Start Your Medical Project
Ready to discuss your medical device manufacturing needs?
Our engineering team is available to review your designs and provide DFM feedback.
