Quality Tech Services LLC (QTS) has received accreditation from MedAccred as the "Global First in Sterile Device Packaging."
“Receiving the Global First in Sterile Device Packaging accreditation from MedAccred is testament to our commitment to being best-in-class,” stated Doug Wilder, QTS founder, in a news release. QTS provides such services as finished device assembly, validated cleaning, inspection, packaging, labeling, sterilization, and supply chain management. It manufactures in Class 7 cleanrooms, is ISO 13485 certified and FDA registered, and has certified microbiologists, packaging engineers, and cleaning specialists on staff.
MedAccred accreditation allows subscribing member companies to ensure suppliers meet quality standards by adhering to global regulations and requirements, while reducing the number, cost, and resources needed for supplier audits, it was described in the release. QTS piloted the Sterile Device Packaging audit process and helped the MedAccred team develop certification criteria for packaging system assembly/filling and sealing of trays. Johnson & Johnson, Medtronic, Stryker, Philips, BD, and Boston Scientific leadership made up the MedAccred team that focused on the development of the audit criteria and process.
“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," stated John Klapperich, vice president of operations at QTS, who was a key facilitator in the audit process at QTS.
QTS's audit process began in early 2019, and the company received official accreditation in November 2019. QTS is privately held by Cretex Companies.
[Image courtesy of QTS (QUALITY TECH SERVICES LLC)]