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Global Medical Device Podcast in 2020

43 episodes, newest first.

  1. 23 DecPost-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry42m
  2. 17 DecTips to Prepare for EU MDR and IVDR as Deadlines Draw Near31m
  3. 9 DecHow will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?39m
  4. 2 DecWhy SaMD Companies Should be Leveraging Pre-Submissions to FDA31m
  5. 26 NovWhat Goes into Designing Devices for Military and Emergency Applications?38m
  6. 18 NovAre you Spending Enough Time Defining and Managing Requirements for your Medical Device?35m
  7. 12 NovPositive and Negative Impacts of EUA on the Medical Device Industry37m
  8. 4 NovWhy Biocompatibility Should be Addressed by Every Medical Device Company48m
  9. 28 OctMeet a Guru: Erica Loring38m
  10. 30 SeptWhat is a Multiple Function Device?41m
  11. 10 SeptChallenges related to Home Use Devices30m
  12. 2 SeptSubmitting a 510(k) using FDA's Safety and Performance Based Pathway45m
  13. 26 AugHow Jon Speer Met His Most Frequent Guest: Mike Drues40m
  14. 19 AugMeet a Guru: Wade Schroeder26m
  15. 12 AugWhat are the Audit Etiquette Rules I Should be Following?36m
  16. 5 AugMeet a Guru: Tom Rish29m
  17. 29 JulAddressing Clinical Trial Challenges & Concerns during COVID-1938m
  18. 22 JulProtecting the Intellectual Property of your Medical Device Technology39m
  19. 15 JulMeet a GURU: Jesseca Lyons37m
  20. 8 JulHow to Build a QMS for a Medical Device44m
  21. 1 JulMeet a Guru: Taylor Brown43m
  22. 24 JunWhat is Regulatory Due Diligence for Medical Devices?41m
  23. 17 JunMass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief33m
  24. 11 JunHow Being Strategic During A Career Transition Can Yield The Best Opportunities39m
  25. 3 JunIdentifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry42m
  26. 27 MayHow to Construct an Effective Regulatory Strategy41m
  27. 20 MayWhat you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)36m
  28. 13 MayHow to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices45m
  29. 6 May510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies43m
  30. 29 AprAddressing the PPE Shortage with a No Cost Solution for Healthcare Providers32m
  31. 22 Apr[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem30m
  32. 15 AprHow to Approach Verification and Validation for Cloud Software39m
  33. 10 AprFighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives24m
  34. 8 AprEmergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know45m
  35. 1 AprHow to Integrate Usability into your Medical Device30m
  36. 26 Mar[LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD)40m
  37. 18 MarHow to Leverage IEC 62304 to Improve SaMD Development Processes37m
  38. 12 MarWhat is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?38m
  39. 26 FebHow to Choose the Right FDA Regulatory Pathway for your Device38m
  40. 19 FebHow to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory36m
  41. 13 Feb4 Parts to Interviewing Candidates for Medical Device Roles34m
  42. 5 Feb5 Tips for Hiring Medical Device Advisors30m
  43. 29 Jan2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 202037m