Technical Files are a Key element in for the success of product approval. Merc will help you identify the most suitable file layout in order to fulfill all possible Regulatory Requirements (MDR 2017/745, US and STED model requirements).
Technical Files contain information about Essential Requirements, Design, Risk Management, Biocompatibility, Clinical Evaluation, Production, Labelling, Post-market surveillance.
We can review the existing data, arrange them in order to meet all requirements, and assist you in completing the most critical areas of your files, such as:
- Review of the device classification according to the MDR Requirements
- Gap analysis of your technical files according to the New Regulation 2017/745.
- Identification of the Essential Requirements
- Identification of the Harmonised Standard
- Risk Management
- Biocompatibility test Plan
- Quality System Procedures
- Post-market surveillance plan and report
- Clinical Evaluation