Whether for economic or strategic reasons, medical device manufacturers often outsource their production to another site or external company. In…
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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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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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At the EPSCO Council meeting last Friday 9 December, the EU Commission presented a legislative initiative to urgently amend the…
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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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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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Adherence to quality requirements for plastic components in MedTech is becoming increasingly important as MDR and IVDR dictate more stringent…
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Many existing medical devices operate on legacy systems, which makes them difficult to maintain and vulnerable to manipulation by hackers.…
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