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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How will the EU Packaging & Packaging Waste Regulation (PPWR) impact the medical device industry?
The European Union’s Packaging and Packaging Waste Regulation (PPWR) represents a cornerstone in the EU’s broader environmental and circular economy…
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ISO 10993-1 | What’s new in the latest draft standard?
ISO 10993-1 provides the governing foundation for the biological evaluation of medical devices, explaining the fundamental requirements and general principles.…
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Post-market clinical follow-up under the EU MDR
Post-market clinical follow-up (PMCF) has become significantly more rigorous under the EU MDR to ensure enhanced patient safety following a…
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