MEDIcept Insights

High-Risk IVDs Drive Immediate Transition to IVDR

High-Risk IVDs Drive Immediate Transition to IVDR

The European Commission (EC) introduced 2017/746, the In Vitro Diagnostic Regulation (IVDR) back in 2017, with a transition period of 5 years, entering into force on 26 May 2022 (with differences for certain articles).  As the deadline loomed, it became apparent that...

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Cybersecurity Post-Market Surveillance

Cybersecurity Post-Market Surveillance

Postmarket surveillance is a crucial aspect of medical device safety and cybersecurity risk management.  It is the primary means of gathering information about how your device performs in the real world so you can make improvements that deliver better diagnoses or...

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Cybersecurity Risk Control

Cybersecurity Risk Control

With a freshly completed threat model in hand, you turn to your next task: create the corresponding cybersecurity risk assessment.  You identified some threat mitigations while constructing your threat model, perhaps making some design decisions intended to limit your...

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