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The mission of Quality System Strategies LLC is to assist medical device companies in establishing quality management systems that

  • Facilitate compliance with regulations
  • Increase business efficiency, and thereby
  • Provide a competitive advantage in the marketplace

How to do it:

  • Aim beyond compliance. Compliance alone is not enough.
  • Simplify documentation. People have to understand what they are expected to do.
  • Connect all the processes. Disconnected processes lead to unhappy customers and worse.
  • Ensure quality is everyone’s job. The Quality and Regulatory groups cannot do it alone.
  • Incorporate product risk management principles throughout the quality management system. Product risk management is not just an add-on for product development.

Bill White
Senior Consultant

 

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© 2011 Quality System Strategies LLC

Contact

Email: wwhite@qualitysystemstrategies.com
Telephone: 574.361.0816