28. April 2023
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.
11. April 2023
Post-market surveillance for medical devices as an efficient process for practicability and added value.
4. April 2023
In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
5. August 2022
Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
21. July 2022
Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
16. May 2022
Medical devices are often highly complex products made of different materials. About the handling of different substances.
25. April 2022
The AET is an essential component for the biological safety assessment of the chemical characterisation of leachable substances in medical devices. Read details about the AET here.
1. April 2022
Qtec Spotlight is our focus on current topics from the medical device life cycle. Every quarter, our experts shed light on a specific area.
25. March 2022
Relevant aspects of biocompatibility of the essential safety and performance requirements for medical devices from Annex I of the MDR.
14. February 2022
Brauchen Klinische Prüfungen und PMCF-Studien eine Prüfung durch die Ethik-Kommission? Erfahren Sie, wie PMCF-Studien einzuordnen sind.
9. December 2021
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.
28. October 2021
We will show you why a quality assurance agreement is an important and central document of the MDR, and should make sure it is always up to date.