The overreliance on post-market clinical follow-up (PMCF) surveys by medical device manufacturers reveals a troubling disconnect between convenience and regulatory rigor. Too many companies are seduced by the apparent simplicity…
Medline’s recent recall of angiographic syringes, coupled with an FDA warning letter, is a stark reminder that even established players in the medical device industry are not immune to quality…
The European Medicines Agency’s recurring meetings with senior pharmaceutical representatives, such as the one held in Amsterdam on April 17, 2026, highlight an ongoing but under-leveraged dialogue between regulators and…
The upcoming HMA/EMA multi-stakeholder workshop on artificial intelligence, scheduled for November 2025, ostensibly promises a critical forum for dialogue among regulators, industry players, and other stakeholders. However, as a healthcare…
The European Medicines Agency’s announcement of a webinar on the new variations guidelines for marketing authorisation holders (human) scheduled for January 13, 2026, signals yet another regulatory update that healthcare…
The announcement of the Committee for Advanced Therapies (CAT) meeting scheduled for January 21-23, 2026, at the European Medicines Agency in Amsterdam is, on the surface, a routine event in…
The European Medicines Agency’s decision to host a live Q&A clinic focused on Substance, Organisation, and Referential Management Services is more than a routine informational session—it’s a clear signal of…
The upcoming Pharmacovigilance Risk Assessment Committee (PRAC) meeting scheduled for January 12-15, 2026 at the European Medicines Agency in Amsterdam represents more than just a routine regulatory checkpoint—it is a…
The pervasive industry tendency to over-classify medical devices under higher risk categories is not just a benign over-cautiousness—it is a strategic failure that undermines the very purpose of risk-based regulation.…
The persistent conflation of medical device and IVD Post-Market Surveillance (PMS) with pharmaceutical pharmacovigilance (PV) is a fundamental misunderstanding that continues to plague regulatory compliance and quality management in our…