A Fortune 500 medical device manufacturer desired to introduce Coordinate Measuring Machine (CMM) capability to reduce inspection time when measuring complex component geometry during incoming inspection. The engineering staff at the medical device company were familiar with the equipment and intended use. However, CMM type equipment had not been previously used or validated at the site.
Performance Validation was contracted by the medical device manufacturer to assist with the development and execution of the deliverables necessary to validate the Zeiss O Select CMM equipment, this included:
The medical device manufacturer accelerated the project schedule. However, Performance Validation was able to deliver the Validation Final Report which released the Zeiss O-Select CMMs for quality assurance inspections per the accelerated schedule. All validation deliverables fully met the medical device manufactures’ quality requirements.
The addition of a qualified and validated Coordinate Measuring Machine (CMM) should reduce the time required to inspect and accept material during incoming inspection, thus increasing the efficiency of the clients inspection process.
The Performance Validation team was able to leverage knowledge of ISO 10360: Acceptance and reverification tests for coordinate measuring machines (CMM) and Quality System Regulations 21 CFR 820.72: Inspection, measuring, and test equipment to ensure all regulatory requirements were met. The PV team was able to leverage knowledge and prior experience with the client’s own quality system and key personnel to anticipate the client’s expectations for documentation processes and acceptance (i.e. validation planning, document development, routing, approval, and reporting) with minimal client resource effort.
About Performance Validation: Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
For additional information please contact:
Medical Device Services Manager
Performance Validation, Inc.
5168 S. Sprinkle Rd
Portage, MI 49002