In this episode, we break down three major global updates impacting medical device and digital health manufacturers: the FDA’s reclassification of skin cancer diagnostic devices, Australia’s new guidance on digital mental health software, and Swissmedic’s 2026 post-market surveillance campaign for higher-risk devices.Note: This episode was created and hosted with AI.

In this episode, MedEnvoy's Regulatory Affairs Consultant Dean Adair shares key takeaways from this year's RAPS Euro Convergence in Lisbon, Portugal, including the MDR/IVDR 2.0, the growing role of AI in medical device regulation, and the biggest compliance concerns manufacturers are facing across Europe.

#rapseuroconvergence #mdr2.0 #ivdr2.0 #aimedicaldevice

Find out about the complexities of Mexico’s medical device regulations, from COFEPRIS registration and distribution to warehousing compliance and technovigilance reporting. Learn what manufacturers need to know to successfully navigate the Mexican market.

Note: This episode was created and hosted with AI.

#cofepris #mexicodeviceregistration #medicaldeviceregistration #medicaldevicecompliance

We break down the four mandatory EUDAMED modules, the biggest compliance challenges medical device companies are facing, and the real consequences of missing the May 28, 2026 deadline. Learn what manufacturers, regulatory importers, and distributors must do now to protect EU market access and prepare for future MDR compliance requirements.

#eudamed #mdr #ivdr #eucompliance #medicaldevices

Note: This episode was created and hosted with AI.

In this episode of Reg with Meg’s Weekly Regulatory Roundup, we break down FDA Recognition List Number 065 and what it means for medical device manufacturers.

#fda #medicaldevices #riskmanagement

Note: This episode was created and hosted with AI.

Listen to our breakdown of the most common COFEPRIS submission pitfalls for medical device and IVD manufactures. Also learn also how to avoid delays when entering your device into the Mexico market.

#cofepris #medicaldeviceregistration #mrh #mexicomedicaldeviceregistration

*Disclaimer: This episode was created with AI

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