12. July 2021Person Responsible – Implementation of Article 15 MDRAs a partner in medical technology, our experts will assume the function of an external responsible person for your company if required.
1. April 2021Regulatory Affairs Updates 13/21Areas: Europe , MDCG updates, COVID-19, IMDRF, USA, Updates, New regulations and guidances "Issue" 13/21
26. February 2021Regulatory Affairs Updates 09/21Areas: Europe, COVID-19, IMDRF, Asia, Myanmar, Australia, Russia, Singapore, Updates, New regulations and guidances "Issue" 09/21
26. August 2019MDR – Art. 88 Reporting of trendsMDR - 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.
1. February 2018Medical Device Regulation: major changes in classification? (1/3)We explain: How big and far-reaching are actually the changes in the classification of medical devices?
1. February 2018Medical Device Regulation: major changes in classification? (2/3We explain what a complete, correct classification according to MDR means and help you avoid typical mistakes.
1. February 2018Medical Device Regulation: Help with classification (3/3)Overview of the most important changes and tips on where to look if you are unsure about the classification.
12. April 2016„qonzentrat“ qtec newsletter – technical articles and publicationsThe qtec newsletter "qonzentrat" draws attention to specialist articles and publications by our experts. Subscribe to first-hand expert knowledge.