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.
