Medtech manufacturing that already meets FDA standards
Medtech manufacturing that already meets FDA standards
Co-engineering and manufacturing of implants and medical instruments at a facility already working to FDA establishment requirements.
When developing implants or medical instruments for a demanding market, you need more than a machining supplier. You need a partner that has built quality, traceability and market access into the supply chain, from the initial design through to series production.
Nijdra’s facility for manufacturing medical implants and instruments is registered with the FDA. Responsibility for obtaining the necessary authorisation for the device remains with the manufacturer placing it on the market. What matters to you is that our facility already works to the requirements associated with an FDA-registered establishment. This can help accelerate your project and reduce risk in the supply chain.
What does this mean for you?
- Less set-up time, less risk. You are not starting from scratch. Processes, documentation and traceability are in place at the level required for medical implants and instruments.
- ISO 13485 combined with FDA experience. A certified quality management system, supported by experience with documentation, audits and batch traceability for this market.
- Co-engineering and manufacturing under one roof. Manufacturability, cleanliness and reproducibility are considered from the design stage. No handover between the drawing board and the production floor.
- A partner to leading OEMs. Recognised with Supplier Performance Awards, among others. Customers choose Nijdra for development and series production, as well as precision machining.
That is why manufacturers of medical implants and instruments choose Nijdra: micron-level precision, support throughout the supply chain and a manufacturing facility familiar with FDA requirements.
Would you like to explore what this means for your product? Get in touch. We would be happy to discuss manufacturability, quality requirements and the path from prototype to series production.