One of Atlas Manufacturing’s medical device projects shows what a well-run Production Quality Plan (PQP) makes possible. This is the story of moving a part from prototype to production under the exacting standards of the medical device industry, guided by a thorough Production Quality Plan.
The Challenge
The project started with a medical device company that had strict quality requirements and complex technical specifications. The goal was to move from prototype to production without compromising the standards the medical device industry demands.
The Timeline
Over nearly two years, Atlas and its partner worked through the phases of the project. The early months went to identifying the critical dimensions and setting up the PQP framework. From there, the teams refined the processes, ran Gage R&R studies, and completed capability studies.
Quality Control
A key part of the work was using the PQP to manage critical dimensions. The first major hurdle was measurement accuracy. The team worked through it and established a repeatable approach to measuring those dimensions reliably.
Milestones
As the project moved forward, the team handled each step in turn, from running PFMEA to producing reliable Test Method Reports (TMRs). The turning point came when the capability studies confirmed the process could produce high-quality parts consistently.
The Results
The project met the quality standards required for the part. The PQP was central to that outcome, keeping production planned and controlled at every step. The FDA’s October 2023 510(k) clearances validated the work.
Conclusion
This project shows how Atlas approaches medical device work: careful planning, disciplined quality practices, and close collaboration with the customer. An effective PQP made the difference between a difficult build and a clean transition to production.
About Atlas Manufacturing
Atlas Manufacturing builds precision sheet metal and fabricated components for demanding industries. Learn more at Atlas Manufacturing.
