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 Beyond clinical risks, devices face technological threats from cybersecurity vulnerabilities to outdated software that can leave patients vulnerable.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. In this second part, they explore how device reporting differs from that for medicines and vaccines, the potential of AI for predictive safety monitoring, and why regulatory and data harmonisation remains key to improving medical device safety.

Subscribe by visiting the Drug Safety Matters website.

TAGS:

You may also like


Rethinking medical device safety part 1 – new podcast episode

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

29 January 2026

ISoP 2025 Cairo: A Global Perspective on the Evolution and Future of Pharmacovigilance

Over 500 attendees from 80+ countries met in Cairo at ISoP 2025, reflecting on pharmacovigilance progress and shaping strategies for its future.

10 December 2025

Patient perspectives in PV at the ISoP Mid-Year Symposium – New podcast episode

Patient engagement was a hot topic at the fireside chat held during this year’s ISoP mid-year symposium.

24 June 2025