Medical devices are everywhere, but monitoring their safety is complex. Omar Aimer discusses the unique challenges of device pharmacovigilance and what needs to change.


From bandages to MRI machines, medical devices touch all our lives, but monitoring their safety is far more complex than for medicines and vaccines. Beyond clinical risks, devices face technological threats from cybersecurity vulnerabilities to outdated software that can leave patients vulnerable.

In this two-part episode of Drug Safety Matters, host Alexandra Coutinho speaks with Omar Aimer, president of ISoP and former co-lead of the Medical Device Special Interest Group. They explore what defines a medical device, why current surveillance falls short, the unique challenges of reporting adverse events, and how global initiatives are working to strengthen safety monitoring standards and protect patients.

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