11. August 2021Regulatory Affairs Update 32/21Areas: Europe, Worldwide, Myanmar, Indian, Australia, Singapore, Canada, China / Updates, New regulations and guidances 32/21
15. July 2021Regulatory Affairs Update 28/21Areas: Europe, USA / Updates, New regulations and guidances 28/21
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.
16. June 2021Regulatory Affairs Update 24/21Areas: Europe, Australia, USA / Updates, New regulations and guidances 24/21
2. June 2021Regulatory Affairs Update 22/21Areas: Europe, Taiwan, Australia, Singapore / Updates, New regulations and guidances 22/21
11. May 2021Regulatory Affairs Update 19/21Areas: Europe, India, Singapore, Taiwan / Updates, New regulations and guidances 19/21
23. April 2021Regulatory Affairs Updates 16/21Areas: Europe, USA, Australia, Malaysia, / Updates, New regulations and guidances 16/21
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.
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.