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May 19, 2023
Tasso, a provider of patient-centric, clinical-grade blood collection solutions, has been recommended for certification from the Medical Device Single Audit Program (MDSAP), under which a single regulatory audit of a medical device manufacturer may satisfy the requirements of multiple regulatory jurisdictions participating in the program. The certification confirms Tasso's compliance with the standards and regulatory requirements of Australia, Canada and the United States, opening potential new global markets for Tasso. Tasso completed its audit on February 16, 2023. Once received, the certification also can streamline the process of reaching additional markets covered under the MDSAP, including Brazil and Japan. The company previously received U.S. Food and Drug Administration Class II medical device clearance. Audits are conducted by auditing organizations authorized by the participating regulatory authorities to audit under MDSAP requirements. Headquartered in Seattle, Tasso is privately held and funded by grants, investments and co-development deals with various industry leaders.