We provide Medical Device Regulatory services including Medical Device Classification, Compiling Device Documentation, Medical Writing and Device Registration.
Medical Device
- Medical Device Registration (MDR) Compliance
- Clinical Study Strategy and Design
- Preparation of Instructions for Use (IFU) and Updates
- Preparation and Update of Technical file
- Clinical Evaluation Reports
- Creation of Clinical Evaluation Plan, Post-Market Surveillance and Post-Market clinical follow-up plans
- Benefit Risk Analysis
