Quality Tech Services (Bloomington, Minn.) said today that it has received the first medical device packaging accreditation from not-for-profit medtech audit provider MedAccred.
MedAccred conducts critical-process audits for its member OEMs to ensure their suppliers adhere to global regulations and requirements. By covering audit needs for multiple OEMs, MedAccred also helps reduce the number of onsite audits for suppliers.
Quality Tech Services piloted the sterile device packaging audit process and help the MedAccred team develop certification criteria for packaging system assembly, filling and sealing of trays. That team included MedAccred member companies Johnson & Johnson, Medtronic, Stryker, Philips, BD and Boston Scientific. The audit process began in early 2019 and accreditation was awarded in November.
“Receiving the global first in sterile device packaging accreditation from MedAccred is testament to our commitment to being best-in-class,” QTS founder Doug Wilder said in a news release.
“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,” added QTS VP of operations John Klapperich.