Resources
Resources to help build a stronger science-based community.
The Science of Compliance
The Science of Compliance podcast, sponsored and hosted by Frestedt Incorporated, is where you can find information about Clinical, Regulatory, and Quality Affairs for medical products including drugs, devices, and even foods.
Featured guest on RA/QA Today
Dr. Frestedt joins this episode to discuss the structure of the new EU-MDR regulations coming into effect.Download the episode on
Episode 2 : Infusing Risk-Benefit Analysis into Clinical Evaluation Reports
Link to episode on Apple PodcastsIn this episode, the Frestedt Incorporated team discusses their recent experience with writing 14 Clinical
Bonus Episode 4: Standards and safety concerns for devices with small bore (luer lock) connections.
Link to episode on Apple Podcasts A review of the standard specifications and testing for Luer lock connections in devices
Episode 1 – Saving Time and Money on Low-Risk Clinical Trials
Link to episode on Apple Podcasts Dr. Joy Frestedt explains why every company can and should be able to carry
Bonus Episode 3 – FDA update on cGMPs for Combination Products
Link to episode on Apple Podcasts An overview of the FDA Draft Guidance on cGMPs for Combination Products, released in
Episode 0 – Welcome to Science of Compliance
Link to episode on Apple Podcasts In this first episode, Science of Compliance welcomes listeners with an interview of the
Bonus Episode 2 – FDA Standards for Unique Device Identifiers and Upcoming Compliance Dates
Link to episode on Apple Podcasts A summary of two FDA webinars discussing Unique Device Identifiers (UDI) and Global Unique
Bonus Episode 1– FDA releases new draft guidance on Low-Risk General Wellness products
Link to episode on Apple Podcasts A play-by-play of the latest FDA CDRH guidance CDRH entitled “General Wellness: Policy for