A Fortune 500 medical device manufacturer wanted to add a new laser welder to their production facility to improve manufacturing throughput and reduce scrap rate. The engineering staff at the medical device company were familiar with the equipment and its intended use; however, this model of laser welder had not been previously used or validated at the company.
Performance Validation was contracted by the medical manufacturer to asses with the development and execution of the deliverables necessary to validate the laser welding equipment. This included:
- Validation Planning
- Project Schedule / Timeline
- User Requirements
- Functional Design Specifications
- IQ / OQ / PQ Development and Execution
- Software Validation
- Data Analysis
- Summary Documentation
Over the course of the project, the medical device manufacturer increased the scope of products to be manufacturing using the laser welder, creating a unique challenge. Performance Validation worked closely with the project team to deliver the Validation Final Report, releasing the equipment for production, on schedule and under budget with the additional products included in the validation scope. All validation deliverables fully met the medical device manufacturer’s quality requirements.
The addition of a qualified and validated laser welding equipment should reduce production time compared to the legacy laser welding equipment at the medical device manufacturer.
The PV Advantage
The Performance Validation team was able to leverage knowledge of ISO 13485: Medical Devices and 21 CFR 820: Quality System Regulation 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.
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Vice President, Michigan Division Director
Performance Validation, Inc