Prince Sterilization Services LLC achieves ISO 13485 certification

PINE BROOK, N.J. — Prince Sterilization Services, LLC, a contract sterilization services provider for the pharmaceutical, medical device, and related industries, announced today that the company received ISO 13485:2016 certification for Medical Device Quality Management Systems. This standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including the sterilization services. To be certified, organizations must demonstrate an ability to provide medical devices or related services in support of the manufacturing of medical devices that consistently meet customer and regulatory requirements. While the standard is specifically geared towards the medical device industry, its contents, together with applicable cGMPs and other FDA guidance’s (21 CFR 210/211 & 820), make up an extremely robust quality management system that also satisfies pharmaceutical and other related industry standards.

“The implementation of ISO 13485:2016 is the best internationally recognized standard to demonstrate that Prince has successfully complied to the laws and regulations of the medical devices industry as a leading provider of contract sterilization services,” said Dr. Daniel Prince, CEO of Prince. Prince’s President, Dr. Derek Prince, continued, “This certification reflects the focus and commitment our organization has on risk-based decision making, safety, and providing a high quality product and service to our customers.”

A copy of our ISO certification can be found on our website under the “resources” tab.

If you have any questions, or would like to discuss working with Prince, please reach out to our Technical Services Department as per below:

E-mail: info@princesterilization.com
Phone: (888) 774-6230