Why Regulatory Affairs Deserves a Seat at the Table with Mike Morton

Mastering Medical Device

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Mike Morton has over thirty years of regulatory, clinical and quality experience in the medical device industry, including serving as Vice President for Corporate Regulatory Affairs at Medtronic, on the Board of Directors for the Regulatory Affairs Professionals Society, and serving on FDA and other regulatory body working groups . In this episode we explore regulatory pathways for devices in the US, Europe and other countries, building relationships with regulators, how things have changed with regulatory agencies worldwide, where companies are launching first and why, what a regulatory affairs professional does throughout the product life cycle, and the importance of regulatory strategy.
Links from this episode:

• Mike Morton Linkedin
• Michael C. Morton Regulatory Consulting
• Regulatory Affairs Professionals Society (RAPS)
• Advamed

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1. Introduction (00:00:00)

2. What Regulatory Affairs is (00:02:59)

3. Getting started in Medical Device and Regulatory Affairs (00:04:13)

4. Small and big company RA (00:07:38)

5. US Regulatory (00:13:36)

6. European Regulatory (00:30:23)

7. Worldwide Regulatory (00:38:33)

8. Regulatory Strategy (00:40:24)

9. A seat at the table (00:45:22)

10. Message to the listeners (00:52:50)

11. Key take-aways (00:53:48)