Younes Medical Technologies (YMT), a wholly-owned subsidiary of Cerebra Health, is pleased to announce that it has successfully transitioned to ISO 13485:2016 and received Medical Device Single Audit Program (MDSAP) certification as of November 2018. YMT is a manufacturer of advanced new technologies for the analysis of sleep and sleep disorders.
This marks a major achievement, offering YMT a significant advantage in commercializing their technologies within Canada — where the certifications are required — but also internationally, as the MDSAP program is intended to consolidate the regulatory standards for multiple nations, streamlining the process of obtaining access to new markets.
The countries currently participating in the MDSAP program include Canada, the USA, Brazil, Japan and Australia, with the potential for other nations to join as the program gains recognition.
YMT strongly believes in the importance of maintaining high standards of quality in their processes, products and services, and acquiring these certifications reflects the company’s continued commitment to this practice.