The role and purpose of medical device regulation is now better understood than at any time in its history, and regulators are no longer seen as gatekeepers preventing business from happening. Graeme Tunbridge, formerly at the MHRA and now a senior VP at leading conformity assessment body BSI, is a champion of the climate of inclusivity.
The role and purpose of medical device regulation is now better understood than at any time in its history, and regulators are no longer seen as gatekeepers preventing business from happening. Graeme Tunbridge, formerly at the MHRA and now a senior VP at leading conformity assessment body BSI, is a champion of the climate of inclusivity.
Challenge, transparency, honesty, unapologetic. These words are sprinkled liberally throughout the conversation I am having with BSI’s Graeme Tunbridge as...
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
