# What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-11-10
- Length: 30m
- Episode: 235
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers
- Listen: https://podcast.greenlight.guru/episode/what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers

## Summary

Tom Rynkiewicz, VP of RA/QA at Raland Compliance Partners, joins host John Spear to discuss the top compliance issues plaguing medical device manufacturers, specifically CAPA, complaints, and design controls. Rynkiewicz argues that these recurring FDA observations stem from flawed internal audit practices that audit isolated quality system components rather than the entire system holistically. He highlights how human behavior and corporate KPIs, such as tracking CAPA turnaround times instead of effectiveness, prevent companies from achieving a true quality culture with zero complaints. The conversation emphasizes the need for system-level auditing and transparency to prepare for potential FDA shifts toward stricter Good Manufacturing Practices (GMP) inspections.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=0) Introduction: Recurring FDA Compliance Issues
- [2:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=175) The Problem with Component-Based Internal Audits
- [9:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=599) Misleading CAPA Effectiveness Metrics
- [14:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=878) Sponsor Read: Greenlight Guru Platform
- [17:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=1067) Raland Compliance Partners Services
- [20:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=1228) The Looming Shift to Pharma-Like GMP Inspections
- [25:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers#t=1530) Building a True Quality Culture and Trust

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Raland Compliance Partners (company)
- FDA (other)
- ISO 13485 (other)
- Abbott Labs (company)
- Patrick Lencioni (other)

## Related episodes from other shows

- [155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach](https://hardwarepodcasts.com/podcast/lets-combinate/2024-09-25-155-fda-compliance-programs-program-7536-000-cder-vs-cdrh-led-inspections-mock-p) (Let's Combinate)
- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (Let's Combinate)
- [178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.