Hardware Podcasts
Global Medical Device Podcast podcast cover art

Global Medical Device Podcast in 2022

55 episodes, newest first.

  1. 29 DecThe Best of Jon & Mike Through the Years50m
  2. 22 DecCDRH Proposed Guidance for FY 202343m
  3. 15 DecFuture of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond43m
  4. 8 DecThe Future of Healthcare & How We Get There48m
  5. 30 NovWhat "Exempt" Means with Respect to Medical Devices & Regulatory52m
  6. 23 NovDeveloping a Regulatory Strategy43m
  7. 17 NovWe Achieved ISO Certification! Now What?43m
  8. 11 NovThe Future of Reprocessed Used Medical Equipment48m
  9. 4 NovThe Importance of Cervical Cancer Screening in the U.S.19m
  10. 2 NovCustomer Discovery for Medical Device Companies38m
  11. 26 OctEUA and the Impending Transition40m
  12. 21 OctCommon QMS Mistakes SaMD Companies Make45m
  13. 13 OctDesign Assurance: The Unsung Heroes of R&D48m
  14. 6 OctLessons from an Industry Leader: Playing the Long Game of MedTech49m
  15. 29 Sept7 Common 510(k) Mistakes and How to Avoid Them55m
  16. 22 SeptBest Practices for Clinical Evidence Management46m
  17. 14 SeptBuilding Your Regulatory Strategy for Commercialization43m
  18. 7 SeptPackaging Validation Best Practices37m
  19. 1 SeptOvercoming Submission Deficiencies due to Biocompatibility29m
  20. 24 AugDoes Your CAPA Process Need a CAPA?51m
  21. 18 AugUDI and the Current State of Global Implementation45m
  22. 10 AugThe Changing Job Market & How It Affects Careers for MedTech Quality Professionals49m
  23. 3 AugDigitizing your SaMD Testing51m
  24. 27 JulExamining FDA’s Refusal to Accept (RTA) Policy and Guidance44m
  25. 20 JulGuerilla Tactics for Quality Leadership53m
  26. 13 JulPreventing the Death of Medical Device Sales48m
  27. 6 JulShifting Sands of SaMD Cybersecurity Regulations33m
  28. 29 JunEarly Stage Territory Planning for Medical Device Companies47m
  29. 22 JunRegulatory & Quality Perspectives of 3D Printing in the Medical Device Industry45m
  30. 16 JunWhat Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?48m
  31. 8 JunEarly Feasibility Studies in Latin America42m
  32. 1 JunSoftware Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry40m
  33. 28 MayApproaching Cybersecurity & Usability as a SaMD Company36m
  34. 25 MayThe Future of Lateral Flow Test Technology43m
  35. 20 MayBuilding a Culture of Quality45m
  36. 18 MayBringing Medical Devices into the Home46m
  37. 12 MayDemystifying the De Novo Process37m
  38. 6 MayChallenges for Regulatory Submission: EU vs. US40m
  39. 4 MayFrom Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE45m
  40. 30 AprThe Future of Cybersecurity40m
  41. 27 AprAchieving Operational Readiness through Good Project Management27m
  42. 20 AprBridging the Gap between Medical Devices and Clinical Data50m
  43. 13 AprNavigating the Medical Device Single Audit Program (MDSAP)40m
  44. 7 AprBringing Augmented Reality MedTech to Market32m
  45. 30 MarMaking Your Informational Meetings with FDA Valuable & Worthwhile36m
  46. 23 MarBuilding Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs28m
  47. 16 MarQMSR: The Future of FDA's Quality Management System Regulation for Medical Devices48m
  48. 9 MarHow Medical Device Intellectual Property Protection Varies by Sector36m
  49. 2 MarHuman Factors & Risk Management: What's Needed & Why?40m
  50. 23 FebWhat are the Opportunities for Improvement (OFI) for Quality?42m
  51. 17 FebOvercoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph34m
  52. 2 FebHow to Select a Contract Manufacturer42m
  53. 26 JanA Regulatory Gap Analysis of FDA's Systems & Policies53m
  54. 12 JanTips for Being Prepared Post-EUA (Emergency Use Authorization)41m
  55. 6 JanUnderstanding the UDI System for Medical Devices34m