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.
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.
28. May 2019Automated Testing in the DevOps contextSoftware testing ensures quality and makes development efficient. Intelligent automation is key to better software and higher customer satisfaction.
26. February 2018Who are you according to the Medical Device Regulation?For each medical device, clarify exactly which role and thus obligations you have as an economic operator! We will help you with this.
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.