Our “ready-to-go” solutions—refined through successful implementations across six companies and two notified bodies—are designed to help you understand exactly what to do and when to do it. By following a strategic process for remediation, we help you avoid the pitfalls of adding unnecessary requirements all at once, ensuring a streamlined and effective compliance journey.
MDR Transition Quality Plan.
This quality plan template will help you define the strategy to align and remediate your company’s Quality System (QS) to the EU Medical Device Regulation. The plan defines the specific approach, role and responsibilities of resources, and sequence of activities relevant to the various assessments of the quality system elements to ensure the roles and MDR implementation have been established.
QMS Velocity
QMS Velocity is an initiative of Operational Velocity, a consulting practice and small-scale manufacturing facility located in Corona, California. We help clients identify and implement cost-saving improvements across their value chain, leveraging our expertise in operations, engineering, and finance as well as 25+ years of experience with Class I, II, and III medical device manufacturers. Our methodologies and demand-response approach to manufacturing have been successfully applied across a wide range of industries around the world.
