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, (European, US and STED model requirements).
Technical Files contain information about Essential Requirements, Design, Risk Management, Biocompatibility, Clinical Evaluation, Production, Labelling.
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:
- Identification of the Essential Requirements
- Identification of the Harmonised Standard
- Risk Management
- Biocompatibility test Plan
- Quality System Procedures
- Clinical Evaluation
- Gap analysis of your technical files according to the New Directive 2007/47/EC