Sleep software maker Younes Medical Technologies, a wholly-owned subsidiary of Cerebra Health, has transitioned to ISO 13485:2016 and received Medical Device Single Audit Program (MDSAP) certification as of November 2018.
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.
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