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CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

Register Now

Panel: How to be an Appraiser in MDDAP

May 1

11:10 AM - 11:45 AM


The FDA’s collaborative pilot program intends to simplify regulatory requirements for medical device makers who are committed to quality manufacturing practices. The pilot program leverages CMMI V2.0 to assess medical device manufacturers against industry best practices and offer improvement opportunities. Find out more about the tailored application of CMMI V2.0 and what it takes to get involved.

Presenters

  • Becky Fitzgerald Principal and Co-Founder Two Harbors Consulting
  • Becky Fitzgerald Principal and Co-Founder Two Harbors Consulting
  • Tom Klein Principal and Co-Founder Two Harbors Consulting
  • Tom Klein Principal and Co-Founder Two Harbors Consulting
  • Jim Shaver Principal and Co-Founder Two Harbors Consulting
  • Jim Shaver Principal and Co-Founder Two Harbors Consulting
  • Mike Ingles Business Excellence and PMO Manager Edwards Lifesciences’ Draper, Utah Plant
  • Mike Ingles Business Excellence and PMO Manager Edwards Lifesciences’ Draper, Utah Plant
  • Lee Simanski Principal Quality Systems Engineer Boston Scientific
  • Lee Simanski Principal Quality Systems Engineer Boston Scientific