Suite Package 2021 - From MDD to MDR: Full Training Suite Package

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.
The program includes exclusive content developed by WCS Faculty and is suitable for professionals at any level of knowledge (beginner to advanced professional) e.g. quality & regulatory affairs specialist and manager.
Some of the top-level QMS procedures will require updates
The most significant QMS gaps are typically in Supplier-Management, PMS, Clinical/Performance Evaluation, Technical Files, Design Control
Obstacles are typically around clear identification of responsibility, resources, unknowns, linkages and practical execution
Speaker:
Dr. H.C. Frank Stein, Medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants