In this episode, we break down New Zealand’s uniquely streamlined regulatory system, where most medical devices don’t require pre-market approval. Instead, manufacturers rely on a notification-based process through the WAND database.

*Disclaimer: This episode was created with AI

Re-listen to our webinar, where our regulatory consultant Brittany Dunning discussed the upcoming UDI registration obligations for both EUDAMED and Switzerland’s swissdamed system, highlighting what companies need to do now to prepare.

#eudamed #swissdamed #webinar

swissdamed is coming and the July 1, 2026 deadline will be here soon. Join MedEnvoy's regulatory expert Brittany Dunning as she breaks down everything medical device manufacturers need to know: CHRN registration, UDI device uploads, timelines, and common pitfalls.

#swissdamed #chrnregistration #medicaldevice

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.

Note: This episode was created and hosted with AI.

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.

Note: This episode was created and hosted with AI.

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

Note: This episode was created and hosted with AI.