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.
Quality Assurance Managers, Internal auditors, anyone involved in the implementation and maintenance of a Quality Management System in the Medical Device Industry.
Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming from
Identity the role and responsibilities of PRRC
Understand how to implement the responsibilities of the QMS
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,