RAQA Today

Podcast by Michelle Lott

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Recent Episodes
  • Medical Device Product Development: From Concept to Commercialization
    Mar 13, 2025 – 00:48:47
  • EU Hot Takes: MDD vs MDR featuring Etienne Nichols and Karandeep Singh Badwal
    Feb 6, 2025 – 00:45:12
  • Biocompatibility for MedTech Professionals
    Dec 6, 2024 – 00:52:21
  • CE Certification vs FDA Submission Strategy: Which is Right for You?
    Oct 1, 2024 – 00:49:45
  • ASCA, CLAP, Fraudulent Biocompatibility Data and You
    Sep 24, 2024 – 00:30:07
  • A Conversation with Vistatec's Life Science In-Focus Podcast
    May 13, 2024 – 00:21:22
  • eSTAR 5.0 - What You Must Know
    Apr 19, 2024 – 00:32:58
  • The Benefits of 3rd Party FDA Reviewers
    Mar 12, 2024 – 00:37:06
  • eSTAR 5.0 Q+A with Patrick Axtell from the FDA
    Feb 20, 2024 – 00:33:52
  • Fractional or Full Time Quality Support: Which is Right for You?
    Feb 7, 2024 – 00:22:49
  • Medical Devices, Cloud Computing and Cybersecurity with Randy Horton
    Nov 29, 2023 – 00:27:56
  • The Business Benefits of Quality
    Aug 11, 2023 – 00:12:12
  • The Joy of Document Control
    Aug 9, 2023 – 00:15:29
  • Make Quality Make $en$e: Management's Role in Quality
    Jul 31, 2023 – 00:37:27
  • MDR By The Numbers: Leveraging New Data for Implementation Planning
    Mar 10, 2023 – 01:18:00
  • EUDAMED Update: January 2023
    Feb 21, 2023 – 00:51:47
  • From the Front Lines of EU Medical Device Regulation
    Jan 31, 2023 – 01:00:55
  • Risk Management - Beyond the Basics
    Dec 13, 2022 – 00:54:31
  • Trends in FDA Initiatives and the Impact on Orthopedic Devices
    Nov 15, 2022 – 00:38:14
  • Free FDA Communications with the FDA? What you Need to Know
    Nov 8, 2022 – 00:50:09
  • Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485
    Oct 31, 2022 – 00:50:51
  • Usability Testing and the FDA
    Oct 25, 2022 – 00:32:35
  • Is your State of Affairs for MDR State of the Art?
    Oct 17, 2022 – 01:03:11
  • MDR, FDA and Other Regulatory Realities
    Sep 22, 2022 – 00:35:41
  • Digital Health: The Future of Medicine and Medical Devices
    Sep 13, 2022 – 00:43:14
  • The End of the COVID-Era EUAs
    Sep 6, 2022 – 00:42:09
  • Crash Course in FDA Submissions
    Aug 31, 2022 – 00:25:10
  • Five Steps to Bring a Medical Device to Market
    Aug 23, 2022 – 00:29:22
  • Design Controls and Risk Management
    Aug 17, 2022 – 01:19:43
  • Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices
    Aug 9, 2022 – 00:47:59
  • The Aftermath Of MDR - Part III
    Jan 25, 2022 – 00:20:32
  • The Aftermath of MDR - Part II
    Jan 6, 2022 – 00:15:23
  • The Aftermath of MDR - Part I
    Dec 16, 2021 – 00:15:40
  • EUDAMED, MDR and Even More Madness with Richard Houlihan
    Nov 23, 2021 – 00:20:04
  • EUDAMED, MDR and Other Madness with Richard Houlihan - Part I
    Nov 3, 2021 – 00:16:33
  • The MDR No Good Very Bad Day: Go To Market Challenges in the EU
    Oct 15, 2021 – 00:12:14
  • The FDA No Good Very Bad Day: Common Regulatory Mistakes
    Sep 29, 2021 – 00:14:51
  • Empowering Female Entrepreneurs and Investors with Faz Bashi
    Jul 13, 2021 – 00:27:48
  • How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull
    May 18, 2021 – 00:19:56
  • FDA Submission Pathways with EIT Health Alumni
    Apr 1, 2021 – 00:32:35
  • All You Ever Wanted to Know About Risk Management with Edwin Bills
    Mar 12, 2021 – 00:44:02
  • Regulatory and Reimbursement - Similar but Different
    Mar 4, 2021 – 00:39:16
  • FDA Device Downclassification - This is Not Good News
    Feb 25, 2021 – 00:26:54
  • Inside a Notified Body with Robert Dostert
    Feb 17, 2021 – 00:02:03
  • Entrepreneurial Roundtable with Elena Kyria
    Feb 11, 2021 – 00:17:15
  • Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product
    Feb 3, 2021 – 00:26:08
  • PPE, Masks and FDA Regulations in the Age of Coronavirus
    Jan 29, 2021 – 00:12:51
  • Regulatory Requirements and the "Simple" Surgical Mask
    Jan 22, 2021 – 00:11:27
  • RAQA Today Becomes leanRAQA Today: What's Next?
    Jan 13, 2021 – 00:26:54
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