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NIS 2 Directive | What it means for healthcare, pharma, and manufacturers of medical devices
On 27 December 2022, Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (NIS…
Congenius
MDCG guidance roundup
As we snap back into action for 2023, here’s a quick roundup of some literature from the MDCG that you…
Congenius
MDR latest | EU Commission calls for urgent amendment
At the EPSCO Council meeting last Friday 9 December, the EU Commission presented a legislative initiative to urgently amend the…
Congenius
How to achieve effective software segregation
The idea of breaking down a complex problem into smaller, more manageable challenges is a well-established concept. In software design,…
Congenius
MedTech news roundup – November 2022
Our November MedTech news roundup covers the recent Swiss-UK MRA, Swiss Parliament’s mandate to the Federal Council to adapt national…
Congenius
Consultant Spotlight – Robert Narloch
Robert Narloch joined us in April this year as an Operations Consultant. In his Consultant Spotlight below, Robert talks to…
Congenius
Keeping Risk, Clinical and PMS connected under EU MDR
It’s undeniable that adherence to EU MDR requirements remains a challenge for everyone involved. And with the complexity of the…
Congenius
Navigating 2022 | Reflections & Learnings
The Swiss medical device industry has faced varied challenges this year, with the COVID-19 pandemic, the ongoing implementation of MDR,…
Congenius
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