In this episode, we break down key compliance obligations, including annual reporting for high-risk devices, adverse event reporting timelines, and Australia’s PRAC process for recalls and market actions. Learn what sponsors and manufacturers must do to stay compliant in the Australian market.

#tgaaustralia #postmarketsurveillance #artg #vigilancereporting #medicaldevice

Note: This episode was created and hosted with AI.

Big 2026 changes from Health Canada are now live. Class II–IV devices must use REP and submit through the Common Electronic Submissions Gateway; email is no longer accepted. We also cover stricter screening, new post-market Terms & Conditions, and IMDRF alignment.

The FDA updated its General Wellness guidance. Here’s what changed for digital health apps, wearables, and low-risk devices and what it means for you.

Join us with MedEnvoy's Director of Consulting Services Daryl Wisdahl, as we discuss the FDA’s transition from QSR to QMSR, the impact of ISO 13485:2016, inspection changes, and key steps manufacturers should be taking now. #QMSR #QSR

In this episode, we cover the most common EUDAMED errors manufacturers make; from Basic UDI-DI grouping and EMDN selection to SRN delays and EU Authorized Representative coordination.

If you’re preparing for EU MDR compliance, this episode gives you practical steps to get it right the first time.

#EUDAMED #EUMDR #MedicalDevices #RegulatoryAffairs

This week's episode, we break down the FDA’s latest 2026 updates: Clinical Decision Support software guidance and the new QMSR for quality systems.

*Disclaimer: This episode was created and hosted by AI*

Since the EUDAMED deadline is approaching, in this episode we’re joined by MedEnvoy’s regulatory consultant, Brittany Dunning, who breaks down the mandatory modules for May 2026, common readiness gaps, UDI and actor registration requirements, and how manufacturers should coordinate with Authorized Reps, regulatory importers, and Notified Bodies to avoid delays.

In this episode, we break down the FDA’s new draft guidance on cuffless blood pressure devices, including smartwatches and wearable tech. Learn what it means for clinical testing, accuracy standards, and regulatory compliance for medical device manufacturers.

*Disclaimer: This episode was created and hosted by AI*