8/21/2025 1:52:19 PM ISO 42001 & the Medical Sector: Where Innovation Meets Trust By Rathin Grover Artificial Intelligence is revolutionizing healthcare—from AI-powered diagnostics and robotic surgery to personalized treatment plans....
10/7/2024 10:49:00 AM From Design to Disposal: Managing Cybersecurity Risks in Medical Devices By Susanna Al Halabi Digital transformation has swept through all aspects of the world over the past few decades, connecting many devices and systems. While...
9/26/2024 7:08:01 AM A Guide to Grace Periods and PSURs under MDR By Susanna Al Halabi In our MDR article series, we’ve briefly touched on the concept of a grace period. This is a transition period of three years for...
5/3/2024 4:01:54 AM State of the Art and MDR Compliance: What Manufacturers Must Know By Susanna Al Halabi The 26 May 2024 deadline for Medical Device Regulation (MDR) is approaching fast, yet, for many medical device manufacturers there is...
3/28/2024 11:18:40 AM Counting down to Medical Device Regulation (MDR) By Susanna Al Halabi The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) marks a notable change in the EU (European...
4/4/2023 4:22:13 PM EU’s decision to extend the Medical Device Regulation transition periods for legacy medical device directives products will be mirrored in the UK By Susanna Al Halabi The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation...
3/21/2023 3:56:55 PM The MDR/IVDR amendment is published in the EU’s Official Journal and has entered into force By Susanna Al Halabi The extension of the MDR transitional period and the deletion of the MDR/IVDR 'sell-off' dates has entered into force. Regulation (EU)...