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.
From surgical instruments to diagnostic equipment, we provide comprehensive manufacturing solutions for the entire medical device supply chain.
Our Medical Manufacturing Capabilities Include:
Precision Medical Mold Tooling
Medical CNC Machining
Medical Injection Molding
Medical Parts & Mold Components
Medical-Grade Materials
The medical industry demands materials that meet strict biocompatibility and sterilization requirements. Our medical components utilize:
√ 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
Medical Device Manufacturing Process
1. Design Collaboration
- Working with medical device engineers to optimize designs for manufacturability
2. Material Selection
- Choosing optimal biocompatible materials based on application requirements
3. Prototyping
- Rapid production of prototype components for testing and validation
4. Tooling Development
- Creating precision tooling for production manufacturing
5. Validation
- Comprehensive process validation including IQ/OQ/PQ protocols
6. Production Manufacturing
- Implementing efficient production processes with rigorous quality controls
7. Sterilization Compatibility
- Ensuring components are compatible with required sterilization methods
8. Documentation
- Complete documentation package including material certifications and inspection reports
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 Aerospace Industry
Our precision manufacturing capabilities serve diverse aerospace 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 components
- 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
Complete documentation and traceability for all aerospace materials
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
Customed Medical Parts
Common Application
With the qualification of ISO13485 automotive industry quality management system certification, Fecision has multiple solutions for Medical part production, aiming to provide qualified products with precision and exellent function.
- Dental Drill
- Scalpel Handle
- Puncture Needle
- CT Scanner Accessories
- Dental Implant
- Prosthetic Connection Parts
- Biopsy Needle Stamping Parts
- Medical Equipment Housing
- Artificial Joint Components
- Orthopedic Screw
Medical Manufacturing Case Studies
Minimally Invasive Surgical Instrument
We developed precision components for a next-generation minimally invasive surgical instrument, meeting tight tolerances and biocompatibility requirements while reducing assembly complexity by 30%.
Diagnostic Testing Device
Our team manufactured critical components for a point-of-care diagnostic testing device, delivering parts with exceptional consistency and reliability for accurate test results.
Implantable Medical Device
FECISION produced high-precision components for an implantable medical device, utilizing biocompatible materials and clean room manufacturing to ensure patient safety and device longevity.
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