In the last part of our series of articles on the topic of “Risk assessment of zoonoses”, we take a look at the planning, scope and process of literature research in accordance with ISO 22442-3.

Which regulations and guidelines apply to materials of animal origin and the risk assessment of zoonoses? We will tell you in part 2 of our series of articles.

Medical devices whose components include materials of biological origin require special risk management. In the first part of our series of articles on “Zoonoses”, we tell you how to meet the requirements of the MDR.

Qtec Spotlight is our focus on current topics from the medical device life cycle. Every quarter, our experts shed light on a specific area.

Assembled medical devices are referred to as systems and procedure packs under the MDR. Separate regulatory requirements of Regulation EU 2017/745 apply to these.

MDR - as of May 26, 2020, a second reporting channel for the disclosure of "non-serious events" or "expected adverse reactions" will be added for all companies.

We explain: How big and far-reaching are actually the changes in the classification of medical devices?

We explain what a complete, correct classification according to MDR means and help you avoid typical mistakes.

Overview of the most important changes and tips on where to look if you are unsure about the classification.