Publications

Our media activities include articles, webinars, and podcasts on core and new MedTech topics.

Articles

  • The Fog at CDRH Is Lifting (a Bit)
    A link to this article is available here.

  • The Only Thing That’s Permanent in Life Is Change
    A link to this article is available here.

  • The Sky Is Not Falling — There's Time To Prep for Quality Management System Regulation's Launch
    A link to this article is available here.

  • Opinion: At Least It’s Not Fruitcake – My Annual FDA Predictions
    A link to this article is available here.

  • Smart Device Firms (and Investors) Unwind Regulatory Risk
    A link to this article is available here.

  • Getting Work Done in the ‘New Normal’ CDRH
    A link to this article is available here.

  • What You Need To Know About FDA Remote Medical Device Inspections
    A link to this article is available here.

  • Advocacy Groups, AdvaMed Vie For Next Phase Of TAP Pilot (Quoted Source)
    A link to this article is available here.

  • Happy New Year – the Sequel
    A link to this article is available here.

  • Digital Health Precertification — The Little Engine That Couldn’t (Yet)
    A link to this article is available here.

  • FDA Isn’t A Monolith. Engage The Agency Better By Answering These 5 Questions
    A link to this article is available here.

  • The Case For Quality — AND Compliance
    A link to this article is available here.

  • QMSR Quick Take: Medtech Consultant Steve Silverman
    A link to this article is available here.

  • Happy New Year! (I Think?): Some 2022 Predictions For FDA’s Device Center
    A link to this article is available here.

  • What Does “Digital” Mean For FDA’s Device Center?
    A link to this article is available here.

  • Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections.
    A link to the article is available here.

Podcasts

  • The Realities Of Real-World Evidence
    A link to to the podcast is available here.

  • FDA’s TAP Pilot
    A link to to the podcast is available here.

  • Medtech Monthly, Ep. 1: Quality vs. Compliance
    A link to to the podcast is available here.

  • The Case For Compliance
    A link to to the podcast is available here.

  • Medical Device Quality
    A link to to the podcast is available here.

  • Real-World Evidence and Data
    A link to the podcast is available here.

  • 2022 Predictions for FDA’s Device Center
    A link to the podcast is available here.

  • MDUFA V User-Fee Negotiations
    A link to the podcast is available here.

  • Digital Devices
    A link to the podcast is available here.

  • Aligning ISO 13485 and the Quality System Regulation
    A link to the podcast is available here.

  • FDA Regulation of Breakthrough Medical Devices
    A link to the podcast is available here.

  • Remote Medical-Device Inspections
    A link to the podcast is available here.

Presentations

  • Learn To Effectively Communicate Regulatory Risk In Business Terms
    A link to the presentation is available here.

  • Discussion with Northwestern University Law School Adjunct Professor Tom Bluth: How Do Business Executives Work Effectively with FDA?
    A link to the presentation is available here.

  • Engaging with the FDA: Best Practices for Dealing with Warning Letters, Seizures, Injunctions — and More – Webinar
    A link to the webinar is available here.

  • Effective FDA Engagement
    A link to the presentation is available here.