MethodSense and LuminLogic – Experience the Synergy of Technology and Expertise
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MethodSense and LuminLogic – Experience the Synergy of Technology and Expertise
Bringing a medical device to market is a complex journey, especially with the FDA’s rigorous regulatory requirements. In this video, we explore the challenges manufacturers face when navigating the regulatory process, particularly when introducing groundbreaking innovations like AI-powered devices. MethodSense, led by industry expert Rita King, provides essential support for regulated companies aiming to ensure…
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How to Structure a New Medical Device Business
There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation.…
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What Happens When the FDA Says, “I Don’t Know”
The FDA tries to track what are called “emerging safety signals.” In 2016, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to fully…
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Navigating FDA Audits with Confidence: Simplifying Compliance for Medical Device Companies
FDA Audits Without Intimidation The healthcare industry, whether it involves pharmaceuticals, biotech treatment protocols, or medical devices, is highly regulated, as it should be. Because the FDA has been established to ensure public safety as the latest healthcare innovations are brought to market, audits will happen. They must. But the audit process doesn’t have to…