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New Cybersecurity Standards for Medical Applications

Leave a Comment / connectivity, cybercriminal, cybersecurity, Digital Health, EU, FDA, ISO 810010501, Medical Device, MedTech, risk mitigation, software / By

New Cybersecurity Standards for Medical Applications     An increasing number of pacemakers, insulin pumps and other medical devices incorporate software and can also connect to the Internet, hospital networks or smartphones. In this way, diagnostic data can be transmitted and evaluated in real time using for instance artificial intelligence (AI), thus allowing anomalies to be …

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The Real Impact of IVDR on Clinical Evidence Requirements

Leave a Comment / benefit risk, clinical evidence, diagnostics, EU, Focus Article, IVDR, Medical Device, MedTech, notified bodies, patient protection, precision medicine, Quality/Regulatory, RC - EU MDR and IVDR / By

The Real Impact of IVDR on Clinical Evidence Requirements     For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …

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