How will the EU Green Deal impact the medical device industry?
The European Green Deal is a set of policy initiatives on climate action laid out by the EU Commission that…
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How to choose the right QMS
Whether you’re part of a large, well-established company with an existing Quality Management System, or involved in a start-up that’s…
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Transferring your manufacturing site | What to consider regarding biocompatibility
Whether for economic or strategic reasons, medical device manufacturers often outsource their production to another site or external company. In…
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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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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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