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 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.
From ideation to commercialization to on-site support for large scale manufacturing, we’ll meet you where you’re at and add value where you need us most.
- Since 2020, we have been quality and operations technical leadership for QMS updates for EU and non-EU manufacturing sites leading to certification.
- We authored and providing procedure updates and direct audit support for surveillance and ‘At Cause’ unplanned audits by FDA and external notified bodies.
- During Covid Pandemic (2020-2024), we were Subject Matter experts for the National Institutes of Health (NIH) supporting the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Target assessments directly impacted over $1.0B of government spending and funding.
- Documentation has been reviewed by quality engineering leaders with experience in orthopedics, diagnostics, and medical device (Class I, Class II, Class III, and Class III implantable)
- Technical guidance and remediation processes has been developed through collaboration of process engineering and quality leaders
