Hardware Podcasts
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Global Medical Device Podcast in 2023

53 episodes, newest first.

  1. 21 Dec#349Climbing the MedTech Career Ladder - How to Get to the Top1h 10m
  2. 14 Dec#348Considerations for IVD36m
  3. 7 Dec#347Human-Centered Design in Medical Devices49m
  4. 30 Nov#346FDAs eSTAR Program47m
  5. 22 Nov#345Using AI In MedTech24m
  6. 16 Nov#344Becoming an Advisor to a Medical Device Company1h 09m
  7. 9 Nov#343Recent FDA Draft Guidances53m
  8. 2 Nov#342Planning an FDA Submission38m
  9. 25 Oct#341What NOT to say to FDA49m
  10. 19 Oct#340LDTs & the FDAs Proposed Ruling46m
  11. 12 Oct#339UDI and the State of EUDAMED1h 02m
  12. 6 Oct#338Site Selection for Clinical Trials54m
  13. 21 Sept#337Moving MedTech Forward - The Past, Present & Future of Greenlight Guru42m
  14. 14 Sept#336From Academia to FDA Clearance (True Quality Roadshow - Boston)42m
  15. 8 Sept#335Accelerating SaMD Development in a Compliant Agile way55m
  16. 31 Aug#334MedTech Funding and Preparing for Due Diligence56m
  17. 25 Aug#333Exploring Breakthrough Device Designation35m
  18. 17 Aug#332Regulatory Strategy and the Advantage of Diversity in MedTech50m
  19. 10 Aug#33128 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues1h 01m
  20. 3 Aug#3303P510k: What Is a 510k 3rd Party Review, and What are the Benefits?40m
  21. 27 Jul#329 The Right Way to Start a QMS: When, How, & What54m
  22. 20 Jul#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices50m
  23. 11 Jul#327 Understanding the ROI of an eQMS51m
  24. 7 Jul#326 CSA vs. CSV: Modern Validation for Modern MedTech1h 08m
  25. 30 Jun#325 The Role of dFMEAs in Risk Management for Medical Devices36m
  26. 22 Jun#324 Management Responsibility: The most important part of a QMS42m
  27. 16 Jun#323 The Combination Products Handbook42m
  28. 7 JunLeaning into Lean Documentation55m
  29. 2 JunCybersecurity and the Future of MedTech1h 12m
  30. 26 MayHow AI Can Help You Manage Risk33m
  31. 24 MayAd Promo and The Difference in Regulatory & Legal1h 26m
  32. 13 MayThe Tools that Make Clinical Investigations37m
  33. 3 MayComplaint Handling with Medical Device Guru, Brittney McIver38m
  34. 27 AprAvoiding Potential Issues with your 510(k) Submission45m
  35. 20 AprMeet a Guru: Brittani Smith29m
  36. 12 AprWhy Building Supplier Relationships Is So Important35m
  37. 5 AprSystematic Literature Review for EU MDR38m
  38. 29 MarBuilding Your Design Controls (and Pitfalls to Avoid)35m
  39. 23 MarMost Common Problems Found During FDA Inspections in 202244m
  40. 15 MarV&V Activities from a Verification Engineer POV - How Hard Could It Be?32m
  41. 9 MarUnderstanding the 'Compliance Manager' Role21m
  42. 2 MarDHF vs. DMR vs. DHR: Understanding the Differences & How They Interact27m
  43. 23 FebHow Communication Affects the Outcomes of Quality Activities48m
  44. 16 FebPart 2: The Theranos Loophole & Lab Developed Tests43m
  45. 10 FebPart 1: The Theranos Loophole & Lab Developed Tests37m
  46. 2 FebImplementing an eQMS after Switching from Paper31m
  47. 26 JanEssentials of Sterilization for Med Device Professionals37m
  48. 21 JanUDI: 10133m
  49. 19 JanQuality Myths and Lessons Learned45m
  50. 14 JanDetermining User Needs for Your Medical Device42m
  51. 12 JanFraud in the Healthcare Industry & the Role of Whistleblowers52m
  52. 7 JanAuditing the Auditor41m
  53. 5 JanWhat is MedTech Lifecycle Excellence?45m