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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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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.
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The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
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Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
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The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
More from Policy & Regulation
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Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
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The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
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Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.