Unique Device Identification (UDI)


The Challenge

A Fortune 500 medical device manufacturer needed to update existing product laser markings to comply with the Unique Device Identification (UDI) FDA Regulation per Code of Federal Regulations Title 21 Volume 8 Part 801 (21CFR801). This involved investigating the different materials that are laser marked and developing the settings for a marked barcode that is compliant with the UDI Regulation. Once developed, the laser marks went through simulated life testing for corrosion and graded to confirm compliance with the UDI Regulation and internal procedures. 

The Solution

Performance Validation was contracted by the medical manufacturer to assist with the development and execution of the deliverables necessary for UDI compliance. This included:

  • Validation Planning
  • Project Schedule / Timeline
  • Design of Experiments (DOE)
  • OQ/PQ Development and Execution
  • Data Analysis
  • Laser Mark File Updates
  • Summary Documentation

The Results

Performance Validation was able to deliver all required validation documentation that updated the products’ markings to comply with UDI regulations. All validation deliverables fully met the medical device manufacturer’s quality requirements and allow the medical device manufacturer to continue selling products that are compliant to the UDI Regulation.

The Benefits

The addition of UDI compliant product markings allows the medical device manufacturer to continue selling products that conform to the UDI Regulation.

The PV Advantage

The Performance Validation team was able to leverage knowledge of ISO 13485: Medical Devices, 21 CFR 820: Quality System Regulation, and the UDI Regulation to ensure all regulatory requirements are 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