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.
1. August 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
21. July 2022
Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
24. May 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22
16. May 2022
Medical devices are often highly complex products made of different materials. About the handling of different substances.
25. April 2022
Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 15/22
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.
16. March 2022
Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 11/22
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.