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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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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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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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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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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How to integrate an ISMS into your existing QMS
In the MedTech industry, information security is not just an IT issue – it’s fundamental to patient safety. MedTech companies…
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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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