Science Of Compliance



Good People Working on Good Projects


  • Episode 2 : Infusing Risk-Benefit Analysis into Clinical Evaluation Reports

    03/03/2015 Duração: 29min

    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 CER writing.   Links to resources in this episode: Med Dev 2.7.1 EN ISO 14971:2012 (link to purchase; […]

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

    17/02/2015 Duração: 05min

    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 the product.   Information on the FDA safety concerns for Luer lock devices: FDA Final […]

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

    05/02/2015 Duração: 19min

    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. Frestedt gives examples of some considerations to make clinical trials accessible, affordable, and appropriate for the needs of […]

  • Bonus Episode 3 – FDA update on cGMPs for Combination Products

    03/02/2015 Duração: 07min

    An overview of the FDA Draft Guidance on cGMPs for Combination Products, released in January 2015.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   Link to FDA Draft Guidance: Current Good Manufacturing Practice Requirements for Combination Products    .

  • Episode 0 – Welcome to Science of Compliance

    31/01/2015 Duração: 39min

    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 Frestedt, PhD, gives some details of her journey from being a one-woman entity to managing her own small […]

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

    23/01/2015 Duração: 05min

    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 referenced in this episode: UDI 101 Presentation Slides: Transcript: Getting Ready for GUDID Presentation Slides: Transcript: […]

  • Bonus Episode 1– FDA releases new draft guidance on Low-Risk General Wellness products

    21/01/2015 Duração: 06min

    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 draft are open for 30 days starting January 20, 2015. Call Frestedt Inc. if you have […]