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MESI, Ltd is pleased to announce that we have successfully added the certificate for conformance with ISO 13485:2016/MDSAP (Medical Device Single Audit Program) to our array of international certifications, including EC and FDA. Following an extensive audit by DQS GmbH, the certificate was awarded to MESI in the beginning of July 2021.

Medical Device Single Audit Program (MDSAP) was established by the International Medical Device Regulators Forum (IMDRF) to allow the conduct of a single regulatory audit of a medical device manufacturer’s quality management system. The aim is to satisfy the requirements of multiple regulatory jurisdictions and improve medical device safety benefitting both the industry and the end user.   

MDSAP represents the highest quality regulatory standard in the medical device manufacturing industry, and it satisfies the relevant requirements of the regulatory authorities participating in the program, including Canada, the United States, Brazil, Australia, and Japan.  

“To MESI, this milestone represents the ultimate recognition by regulatory authorities of the effort to maintain the highest quality standards. The obtained certification was a result of strict review of all internal and external processes, and we are proud of the fact that we can now serve an even wider market with our top-notch diagnostic devices,” says Jakob Šušterič, CEO of MESI. This brings MESI one step closer to fulfilling the company’s mission: bringing timely diagnostics and, consequently, successful treatment into healthcare practices across the globe.