When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.
Interpreting and applying Rule 11, the classification rule for software which falls under the Medical Device Regulation’s Annex VIII, is proving challenging for the medical device sector.
The wording has been heavily criticized – not only by medtech manufacturers but by companies unused to medtech regulations, such...
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
