Medical Device News June 2026 Regulatory Update
Sponsor Medboard EUROPE UK Easy Medical Device solutions Rest of the World Podcast Easy Medical Device Social Media to follow The post Medical Device News June 2026 Regulatory Update appeared first o...
3 Jun 0s
FEEDBACK AFTER 3 MONTHS OF THE NEW FDA QMSR IS IN PLACE
The FDA’s new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for n...
28 Mai 0s
How can a proper Intended Use save your device?
A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy. In this podcast episode, Monir El Azzouzi speaks with […] The post How can a p...
21 Mai 0s
Medical Device News May 2026 Regulatory Update
Europe Switzerland UK Events International Podcast Easy Medical Device Social Media to follow The post Medical Device News May 2026 Regulatory Update appeared first on Medical Device made Easy Podcast...
13 Mai 0s
Can You Certify an LLM-Driven Medical Device?
Large Language Models (LLMs) such as ChatGPT, Gemini, and Claude are rapidly transforming digital healthcare. From clinical decision support to medical documentation and patient interaction, generativ...
7 Mai 0s
Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand
The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry. Now, Europe is introducing an additional layer: Master UDI-DI — a...
30 Apr 0s
Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it […] The post Life A...
22 Apr 0s
The Fake QMS Problem: Why Your ISO 13485 System Will Fail an Audit
Many medical device companies believe they have a compliant Quality Management System (QMS). On paper, everything looks perfect:• Procedures are written• Forms are available• Risk management is docume...
16 Apr 0s
