MEDICAL DEVICE SOFTWARE DEVELOPMENT CONSULTING

 

Carl has more than 40 years of industry experience in the area of Medical Device Software 
Development. His responsibilities have included medical device software management and
development, medical device software quality assurance, software standardization, 21 CFR
Part 11 ​compliance, and the management of worldwide information systems and services. 


Speaking Engagements

Carl has been a regular speaker at several Medical Device industry forums including:
  - AdvaMed (Advanced Medical Technology Association) 2011
  - AAMI (Association for the Advancement of Medical Instrumentation)
  - MD&M (Medical Design and Manufacturing)
  - OCRA (Orange County Regulatory Affairs) 2012

  - Software Engineering Institute TSP Symposium 2011 - SEPG 2012 - TSP Symposium 2014 ACE 2014

  - IEEE Orange County Computer Society 2006

Articles

Medical Device Software Safety, Quality, and Compliance: What Really Makes A Difference? - MedTech Intelligence (October 19, 2015)

Developing High-Quality-Medical Device SoftwareMedTech Intelligence (December 15, 2012)


AdvaMed/FDA Software Working Group

He was an active member of the AdvaMed Software Working Group for more than 25 years and was co-author of an AAMI Technical Report - AAMI TIR36:2007 Validation of Software for Regulated Processes.

University of California, Irvine

Carl is a member of the advisory committee of the Medical Product Development Certificate Program - University of California, Irvine Extension Program where he also has taught a specialized course on medical device software development.  

Carl is a:
  - Certified ScrumMaster

Over a 3-year period, he successfully led the implementation of the TSP/PSP in a major medical device company which included multiple projects with more than 200 developers.  

He has personally trained and coached several large teams including over 100 software development personnel (team leads, developers, and testers). 

He has also personally trained and coached more than 17 hardware engineers in the use of TSP/PSP practices for hardware development.

Personal Software Process(SM), PSP(SM), Team Software Process(SM), and TSP(SM) are service marks of Carnegie Mellon Type your paragraph here.

Carl Wyrwa

Carl is an expert at helping software development organizations implement improvements to their software development processes in order to achieve excellence in the areas of Software Safety, Software Quality, and Software Compliance.