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…
Congenius
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…
Congenius
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…
Congenius
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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Medical device reimbursement | 5-minute guide
Medical device reimbursement refers to the process by which manufacturers, healthcare providers, and patients obtain financial coverage for medical devices…
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Navigating the regulatory landscape of fast-growing markets | South Africa
The growth of South Africa’s medical device market has been largely driven by increased healthcare demand due to an aging…
Congenius
Congenius appoints Dr Sarah Bosshard as new Head of Clinical
We are delighted to announce that Dr Sarah Bosshard has been appointed as our new Head of Clinical. Since joining…
Congenius