Composite and Biopolymers
Our Materials.
We can provide support in the development of medical device made of biopolymers materials, in particular:
- Carbon fiber composite instruments
- Radel Instruments
- Carbon Fiber Implants
- Bioabsorbable Implants
- Design & Engineering
- Quality & Validation
- Regulatory Support
- International Medical Device Registration Support
- MDR 2017/745
- European Authorized Representative Service
- EU PRRC
- EU MDR Importer Support
- CH-REP & Swiss Authorized Representative service
- China Market Access Medical Devices
- Clinical Evaluation
- DHF Design History File
- Risk Management Process
- ISO 14971 Gap Analysis
- Design Control Process
- EUDAMED support
- FDA Submission
- IVDR Compliance Support for In Vitro Diagnostics
- Testing
- Electronic IFU
- Blog
- Contact Us / Ask for a Quotation
