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Link to episode on Apple PodcastsIn this episode, the Frestedt Incorporated team discusses their recent experience with writing 14 Clinical Evaluation Reports (CERs), including the purpose and scope of these reports and some tips to address common pitfalls they observed
Link to episode on Apple Podcasts A review of the standard specifications and testing for Luer lock connections in devices used in the gastrointestinal systems. Learn about the FDA safety concerns with these devices and suggested testing to show risk
Link to episode on Apple Podcasts Dr. Joy Frestedt explains why every company can and should be able to carry out clinical trials to ensure safety and demonstrate efficacy of their product. Low-risk clinical trials are discussed, including claims substantiation
Link to episode on Apple Podcasts An overview of the FDA Draft Guidance on cGMPs for Combination Products, released in January 2015. Learn how to decide which GMPs win when working with devices where both drug and device regulations apply.
Link to episode on Apple Podcasts In this first episode, Science of Compliance welcomes listeners with an interview of the Frestedt Incorporated staff to discuss what it’s like to work in the clinical trials, regulatory affairs, and quality systems fields.
Link to episode on Apple Podcasts A summary of two FDA webinars discussing Unique Device Identifiers (UDI) and Global Unique Device Identifier Database (GUDID). Learn what information is incorporated into UDIs and what devices are affected by UDI and GUDID
Link to episode on Apple Podcasts A play-by-play of the latest FDA CDRH guidance CDRH entitled “General Wellness: Policy for Low Risk Devices.” Learn what defines a low-risk general wellness product, and how to tell if YOUR product falls under