A Fortune 500 medical technologies firm wanted to reduce the manual input and cycle time when building battery cell clusters for their battery driven devices by installing a robotic welding station. The engineering staff were knowledgeable in the equipment and intended process flow, but since this was a novel station, no one had previously qualified a complex automated station or the SCADA and PLC systems required for the process at this site.
Performance Validation was contracted by the medical device manufacturer to assess the quality system requirements, develop, and execute the deliverables required to validate the automated robotic welding station. These deliverables include:
Performance Validation was contracted while the process was being developed and was able to assist in project scheduling and timelines.
Performance Validation was able to deliver the Validation Final Report, releasing the equipment for production on schedule and under budget. All validation deliverables fully met the medical device manufacturer’s quality requirements and will be used as a template for future validation projects which will incorporate this level of automation.
The completion of validation requirements for this station allowed for a reduced cycle time for battery cluster assemblies while reducing potential errors from batteries being manually loaded prior to welding. This equipment allowed for additional capacity of production for multiple products which was not possible with the old manual production line.
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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Performance Validation is a 100% employee-owned company 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 validation for a steam autoclave manufacturers.
We are not a virtual company, a staffing agency, or a “body shop.” Our projects are managed and staffed by our own employees. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 30 years.
For additional information please contact:
Vice President, Michigan Division Director
Performance Validation, Inc