The Challenge

A Fortune 500 medical technologies firm wanted to increase the production capacity for its products.  The intention was to increase capacity with a new production line that was also prepared for future products to be added to the line with minimal changes.  This plan saw the addition of a new SCADA controlled production line with complex equipment integration to be used in future expansions.

The Solution

Performance Validation was contracted by the medical device manufacturer to assess the quality system requirements, develop, and execute the deliverables required to validate the new production line.  These deliverables include:

  • Validation Plan
  • Factory Acceptance Testing
  • User Requirements and Requirement Traceability Matrix
  • Equipment and process IQ / OQ / PQ
  • Manual Process Validation
  • Measurement System Analysis / Test Method Validation
  • SCADA computer system validation / qualification and build order verification
  • Validation Final Report

Performance Validation was contracted while the process was being developed and was able to assist in project scheduling and timelines.

The Results

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 for product launch.

The Benefits

The completion of validation requirements for this production line allowed for additional production capacity for current products with an easily expanded product list.  Future products will be able to use the qualified equipment and SCADA system to produce quality products for the consumer without an overhaul of the current production line, which will minimize line shutdown time.

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.


Have a question on Medical Device manufacturing validation? 

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John Underwood
Vice President, Michigan Division Director

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