The AI Act | An updated overview
As mentioned in last week’s article – The Data Act’s relevance in 2026, back in 2024, the EU regulatory environment…
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The Data Act’s relevance in 2026
In 2024, the regulatory environment in the EU regarding data became more complex, as three horizontal digital EU Regulations and…
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Sustainability in plastics manufacturing for medical devices
Sustainability remains one of the most complex challenges facing the MedTech industry. It’s a broad, often polarising topic, and many…
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EU proposed MDR & IVDR update | What’s in the proposal?
On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and…
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ISO 10993-1:2025 | What’s new in the revised standard?
Back in June, our Senior Operations Consultant and Biocompatibility Specialist Dr. Silvio Peng shared five important updates from the draft ISO…
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Risk Analysis vs FMEA – What’s the difference?
According to ISO 14971, legal manufacturers are required to perform a Risk Analysis for their medical devices. However, the expectation is that…
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How real-world evidence can strengthen your clinical strategy
Used in diverse real-world settings, medical devices often undergo rapid iterations – encountering varying levels of operator skill within changeable…
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How to maintain an effective QMS
Maintaining an efficient and effective Quality Management System (QMS) over time is a substantial challenge. But what makes it so…
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