MedTech news roundup – January 2023
Our January 2023 MedTech news roundup covers the latest from Swissmedic regarding its strategic goals for 2023-2026 and advice on…
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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…
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MDCG guidance roundup
As we snap back into action for 2023, here’s a quick roundup of some literature from the MDCG that you…
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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…
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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,…
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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…
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Consultant Spotlight – Robert Narloch
Robert Narloch joined us in April this year as an Operations Consultant. In his Consultant Spotlight below, Robert talks to…
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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…
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