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ISO 10993-1 | What’s new in the latest draft standard?

11/06/2025

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

14/05/2025

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

07/05/2025

In the MedTech industry, information security is not just an IT issue – it’s fundamental to patient safety. MedTech companies…

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Medical device reimbursement | 5-minute guide

09/04/2025

Medical device reimbursement refers to the process by which manufacturers, healthcare providers, and patients obtain financial coverage for medical devices…

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