A leading medical device manufacturer sought to add a new product to an existing production line. This required a retrofit of the previously validated line, requiring an assessment to determine if existing documentation met current regulatory standards. Additionally, new processes and simple fixtures were being added to the production line to accommodate the new product.
Performance Validation was contracted by the medical device manufacturer to assist with the assessment of the legacy validation documentation as well as development and execution of the deliverables necessary to validate production line for new product. This included:
- Master Validation Planning
- Project Schedule / Timeline
- Legacy Documentation Assessment
- Gap Analysis
- IQ / OQ / PQ Development and Execution
- Test Method Validation Development and Execution
- Summary Documentation
The medical device manufacturer was able to launch its new product on schedule and within budget. Legacy documentation was assessed, and revalidation was performed where required. All validation deliverables fully met the medical device manufacturer’s current quality requirements.
The client was able to gain peace of mind that their new product and existing production line met regulatory validation requirements, while also launching a new product to gain market share.
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