What does true quality mean? How does it relate to compliance?

Today’s guest on The Global Medical Device Podcast is George Zack of Two Harbors Consulting. 

George shares his thoughts on these two tough questions and describes his involvement with the FDA’s Case for Quality Program and CMMI Institute’s Medical Device Discovery Appraisal Program (MDDAP).



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Some of the highlights of the show include:

  • MDIC oversees programs developed to assess organizations’ beyond compliance of regulations to produce quality products.
  • Capability Maturity Model Integrated (CMMI): Third-party appraisal is performed against participating manufacturing organization to provide feedback.
  • Besides getting the appraisal and feedback, participating facilities are eligible for some regulatory modifications and benefits.
  • Compliance vs. Quality: Devices need to not only be compliant, but safe, effective, and readily available.
  • There are similarities and differences between practices, assessments, appraisals, and audits. Don’t prepare or study; be open and transparent.
  • Understand how the business operates to see the big picture. Practice areas include product integration, configuration management, and incident resolution.
  • FDA’s Medical Device Single Audit Program (MDSAP) can involve more money, time, and people. MDDAP strives to be non-interruptive, streamlined, and faster.



Two Harbors Consulting

CMMI Institute - Medical Device Discovery Appraisal Program (MDDAP)

FDA Case for Quality Program

FDA Case for Quality: 2018 Comprehensive Review

Medical Device Innovation Consortium (MDIC)

MDIC Annual Public Forums

MDICx Webinar Series Part 1

MDICx Webinar Series Part 2

MDICx Webinar Series Part 3

MDICx Webinar Series Part 4

Dr. Jeff Shuren

Medical Device Single Audit Program (MDSAP)

Premarket Notification 510(k)

Greenlight Guru



The facilities that participate are also eligible for some regulatory modifications. - George Zack 

We’re not just looking for devices that are compliant. We are looking for ones that are going to be safe and effective. Are they also readily available? - George Zack

With this appraisal program...engineers are more likely to bring these changes to the surface. To enable changes is to enable opportunities for improvement. Jon Speer



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