Scope of the training

A Medical Device training to learn to about the basic requirements and the upcoming changes to the Medical Device regulations (MDR) in Europe. It will span from pre-market to post-market, it will cover classification of Medical Devices, how to get in compliance with the new MD regulation in Europe, explanation of the major changes to the current Directive. But it will also cover the regulatory side and importance of the supply chain of products. The new terms Clinical Evidence will be explained and the impact to a safe product as well hot topics like biocompatibility, sterilization , borderline products, risk management will be presented and discussed.

Goals

• You will learn about best practice to implementation of the MDR regulation
• You will be able to discuss your MDR challenges with experts with profound knowledge from the appropriate area
• You will attend a compact (2 days) training program.

Target Audience

Local regulators in the field of pre-and post-market controls MedTech industry, MDR manufacturers, regulatory affairs managers, distributors, importers.