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Speaking Of Medtech, Ep. 8: Medical Device Quality
In this episode of Speaking Of Medtech: Too often quality is overshadowed by regulatory and compliance, and some manufacturers view quality as an obstacle to getting product into the marketplace rather than a concept that will help a company save money, reputation, and patient lives.
More from Regulation
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A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
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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.
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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.
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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.
More from Policy & Regulation
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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.
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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.
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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.