Global Medical Device Podcast powered by Greenlight Guru

398 Folgen

1. Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

   Vom: 7.11.2019
2. Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

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3. How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

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4. How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

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5. Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

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6. Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

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7. Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

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8. An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

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9. Medical Device Product Development Project Management Best Practices with Peter Sebelius

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10. Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

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11. The Difference Between Intended Use and Indications of Use with Mike Drues

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12. How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

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13. Integrating Business Elements into Your Product Development Process with Therese Graff

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14. Tips to Help You Prepare for an FDA Inspection

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15. What Device Makers Need to Know About Design Verification and Validation with Mike Drues

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16. Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

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17. Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

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18. Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

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19. Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

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20. How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

    Vom: 7.11.2019