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
Manufacturers struggle to address requirements for clinical evaluation for all classes of devices, with many erroneously assuming class I devices will not need clinical data.
Understand the requirements of the latest ISO 14971 version
Learn about changes between ISO 14971:2012 and ISO 14971:2019
Learn the level of the required depth of evidence needed
Speaker:
Dr. H.C. Frank Stein, Medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology,