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...
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
