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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MedTech news roundup October 2025
Our October MedTech news roundup covers new harmonised standards from the EU Commission, the latest on swissdamed, and guidances from…
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MedTech news roundup September 2025
Our September 2025 MedTech news covers the latest regulatory updates from the EU, Switzerland, China, Canada, and Brazil. Find out…
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MedTech news roundup Summer 2025
Our summer MedTech roundup gathers the latest in industry news from July and August from regulators around the world. Find…
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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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MedTech news roundup June 2025
Our June 2025 MedTech news covers the recent guidance from the MDCG on the interplay between the MDR/IVDR and the…
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MedTech news roundup May 2025
Our May 2025 MedTech news covers the Swiss Federal Council’s guidelines for expanding medical devices supply, an upcoming focus campaign…
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MedTech news roundup April 2025
Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR,…
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