Webinar: Software as a Medical Device (SaMD) – Regulatory fundamentals

10 March 2021 | 03:00-04:00 p.m.

In the course of the digitalization of the healthcare system, more and more software is being used that has to be directly qualified as a medical device or in-vitro diagnostic. The webinar provides you with valuable insights into the conformity assessment procedure and you will learn about the basics of certification.

With the Mazars webinar series on medical devices and digital services for the healthcare market, all economic actors (manufacturers, distributors, importers, operators and users) receive valuable information on the regulatory requirements as well as the legal and economic framework conditions of the German healthcare system.

Our third webinar “Software as a Medical Device (SaMD) – Regulatory fundamentals” on 10.03.2021 from 03:00-4:00 p.m. focuses on digitalization and the use of software in the healthcare sector. Our experts provide you with valuable insights into the conformity assessment procedure including required steps and efforts. You will learn about the basics of certification with a view to the preparation of the technical documentation and the clinical evaluation. Considering the effective date of the Medical Device Regulation on 26th May 2021, valuable information will also be provided on the transitional regulations.

The webinar will be organized in cooperation with Dr. Dietmar Schaffarzcyk, External Auditor Medtech and expert on methods and requirements of quality systems, product documentations and clinical evaluation.

We look forward to welcoming you to our webinar!

Register now