Medical Device Contract Manufacturing
In addition to designing your medical devices, FDI is uniquely equipped to be your contract manufacturing partner, whether you are ready for new product introduction or already in full production. We have the facility, staff, certifications, and expertise to manufacture your medical devices, covering all stages of production from fabrication and assembly to packaging and distribution.
We are committed to quality in every device we produce. Our Quality Management personnel verify that every client’s specification is met while also complying with all necessary regulatory requirements. We are experienced in designing and fabricating products to meet FDA requirements, and our facility is inspected routinely and certified in the following areas:
- ISO 13485 Medical Device Quality System
- Medical Device Single Audit Program (MDSAP) – FDA and Health Canada participant
- ISO 14971 Risk Analysis
- FDA 21 CFR 820 Good Manufacturing Practices (cGMP)
Our ultimate goal as a medical device company is making safe and effective products that improve lives.
Advantages of Working with FDI as Your Contract Manufacturing Partner
- Third-party quality inspectors
- Entire team of full time Engineers on staff
- Defined project management process from product design to commercialization
- Supply chain analysis and management
- Fully integrated ERP system
- 90,000 sq.ft. temperature-controlled, FDA-registered facility
- Inventory and warehousing
- Experienced factory acceptance testing and quality assurance teams
- Highly trained skilled labor force
- Scalable manufacturing processes
- Latest equipment in welding, 3D printers, CNC machines, and other equipment
- Fixture design and fabrication
- High-quality final products
- Easy-to-read operations and service manual development
- Marketing professionals to help with advertising, promotion, and web sites