In 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 during

Bonus Episode 4: Standards and safety concerns for devices with small bore (luer lock) connections.

Feb 17th, 2015 5m 41s

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 has been designed out of th

Episode 1 – Saving Time and Money on Low-Risk Clinical Trials

Feb 5th, 2015 19m 46s

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 trials, and Dr.

Bonus Episode 3 – FDA update on cGMPs for Combination Products

Feb 3rd, 2015 7m 59s

An overview of the FDA Draft Guidance on cGMPs for Combination Products, released in January 2015.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 Link to FDA Draft Guidance: Current

Episode 0 – Welcome to Science of Compliance

Jan 31st, 2015 39m 42s

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. Additionally, CEO Joy

Bonus Episode 2 – FDA Standards for Unique Device Identifiers and Upcoming Compliance Dates

Jan 23rd, 2015 5m

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 registration. Links r

Bonus Episode 1– FDA releases new draft guidance on Low-Risk General Wellness products

Jan 21st, 2015 6m 31s

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 this guidance. Comments on this dr

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