Medical Device Line Retrofit


The Challenge

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.

The Solution

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 Results

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 Benefits

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.

Contact

Have a question on Medical Device manufacturing validation? If so, please contact us using use our Contact Us form and one of Performance Validation’s team will be in touch.

About Us

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:

John Underwood
Vice President, Michigan Division Director
Performance Validation, Inc
Desk: 269-364-2752
Cell: 269-217-0353