Training
Trainings are custom-made, specifically for your field of activity and for your medical devices in order to meet your expectations. They are adapted to the level of knowledge of your teams.
ADEQUAT EXPERTISE is registered as a training organism under the number of activity declaration 54 17 01405 17.
REGULATION
- The new european regulation 2017/745
- Post-market surveillance, vigilance and market surveillance
- Obligations for economic operators: manufacturers, distributors, importers and authorized representatives
- Clinical evaluation : new regulaotry regulatory requirements
- FDA – American regulation related to medical devices 21CFR Part 820
- Writing a technical file according to regulation 2017/745 requirements
QUALITY MANAGEMENT / VALIDATION
- Understand and set up the ISO 13485 standard
- become an internal auditor
- Conduct audits effectively at subcontractors and suppliers
- Risk management : implementation of the standard ISO 14971 standard
- Implementation of a validation master plan
