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Medical Devices 101: An Entry Level Overview of the FDA

If you're a startup or small company looking to bring a new device to market, dealing with the FDA can be overwhelming. The list of questions can seem endless - What product code do I need? What's the best submission pathway for my device? Where can I find information about predicate devices? What is ISO 10993 and why does it matter to my device? Listen in as Michelle explains all this and more, clarifying the various processes and laying a foundation for your interactions with FDA. Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 medical device regulation, FDA 510(k), medical device classification, FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, risk management, quality management system, risk management plan, quality management, risk management strategy, quality management in healthcare, risk analysis and management, quality management system medical device, risk assessment matrix, FDA submission, FDA 510k submission guidance