Cretex Medical | QTS, a leader in medical device outsourcing solutions, has received accreditation from MedAccred® as the Global First in Sterile Device Packaging.
December 27, 2019
Cretex Medical | QTS receives accreditation from MedAccred.
BLOOMINGTON, MN – Quality Tech Services, LLC (QTS), a leader in medical device outsourcing solutions, has received accreditation from MedAccred® as the Global First in Sterile Device Packaging.
MedAccred accreditation allows subscribing member companies to ensure suppliers meet the highest quality standards by adhering to global regulations and requirements while reducing the number, cost, and resources needed for supplier audits typically performed by those same member companies.
Doug Wilder, QTS Founder, stated, “Receiving the Global First in Sterile Device Packaging accreditation from MedAccred is a testament to our commitment to being best-in-class.”
QTS piloted the Sterile Device Packaging audit process and was instrumental in helping the MedAccred team develop certification criteria for packaging system assembly/filling and sealing of trays. The MedAccred team that focused on the development of the audit criteria and process consisted of leadership from Johnson & Johnson, Medtronic, Stryker, Philips, BD, and Boston Scientific.
John Klapperich, Vice President of Operations at QTS was a key facilitator in the rigorous audit process at QTS. He noted, “QTS has been audited many times by very experienced and knowledgeable auditors, but the MedAccred audit, focused specifically on sterile barrier packaging processes, was the most beneficial to enhancing this aspect of our business.”
QTS successfully worked through the intensive audit and approval process performed by MedAccred and its subscribers. The audit process began in early 2019, with QTS receiving official accreditation in November 2019.
QTS provides critical end-of-line services to medical device OEMs. Capabilities and services include finished device assembly, validated cleaning, inspection, packaging, labeling, sterilization, and supply chain management. QTS manufactures in Class 7 cleanrooms, is ISO 13485 certified, FDA registered, and has certified microbiologists, packaging engineers, and cleaning specialists on staff. QTS has over 18 years of experience providing quality outsourcing solutions to the medical device industry and is privately held by Cretex Companies. More information about QTS capabilities can be found online at www.qtspackage.com.
MedAccred® is an industry-managed supply chain oversight program that reduces risk to patient safety, and assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. The program is administered by the not-for-profit Performance Review Institute®. PRI is a global provider of customer-focused solutions designed to improve process and product
PRI works closely with the industry to understand their emerging needs and offers customized solutions in response. Learn more at www.MedAccred.org