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Zentek Receives ISO 13485:2016 Certification
GUELPH, ON / ACCESSWIRE / May 18, 2023 / Zentek Ltd. (" Zentek " or the " Company ") (Nasdaq:ZTE...
About this update from Zentek Ltd.
[{"type":"text","content":"Zentek Receives ISO 13485:2016 CertificationGUELPH, ON / ACCESSWIRE / May 18, 2023 / Zentek Ltd. (\"Zentek\" or the \"Company\") (Nasdaq:ZTEK)(TSXV:ZEN), a graphene technology development and commercialization company has been granted ISO 13485:2016 Quality Management System (QMS) certification standard by British Standards Institution (BSI). The company has also received Medical Device Single Audit Program (MDSAP) certificate # 777967. These certifications validate Zentek's robust QMS that can handle all regulated products and demonstrate safety, reliability, and quality.ISO 13485:2016 is an internationally recognized quality standard for the medical device industry that supports the quality of medical device design, development, and production. MDSAP is currently utilized by Canada, the United States, Japan, Australia, and Brazil.Under the supervision of Vivian Martin, Director of Global Regulatory Affairs, Zentek developed and implemented a state-of-the-art QMS system specific to Zentek. The QMS was developed in-house and is wholly owned by Zentek. This QMS not only combines the requirements of ISO 13485:2016 and MDSAP, but also Medical Device Regulations (MDR) for the European market. The company has been audited for all 3 QMS systems and expects to receive certification for MDR once a final review of the audit report has been completed. The company will report when this certification is received. These certifications will facilitate new approvals for ZenGUARD™ surgical masks and other medical devices in other global markets. The company will report when it receives such approvals in new countries.\"We are very proud of the hard work by our Quality and Regulatory team to successfully complete the rigorous process to become an ISO 13485:2016 certified company. This reflects the dedication Zentek has to Standard Operating Procedure-driven processes and to continuous improvement, along with our commitment to safety and consistent quality products,\" said Greg Fenton, CEO of Zentek. \"Our partners, suppliers and customers can be confident that Zentek products are manufactured with stringent quality control and SOP-driven processes.\"About ZentekZentek is an ISO 13485:2016 certified graphene technology company focused on the research, development, and commercialization of graphene-based novel products to give its commercia...