SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, today announced that it 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.
“We’ve continued to expand both our offerings and the markets we serve to meet increasing demand for simple, convenient, patient-centered care worldwide,” said Ben Casavant, PhD, CEO and co-founder of Tasso. “This certification is a critical step forward in offering our blood collection solutions for decentralized clinical trials and home diagnostic testing to additional markets and reinforces our commitment to quality and safety.”
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 (FDA) 510(k) Class II medical device clearance for its Tasso+™ lancet, as well as CE Mark certifications for its TassoOne™ Plus and Tasso-M20 devices.
The MDSAP program is part of the International Medical Device Regulators Forum. Members include the Therapeutic Goods Administration of Australia; Brazil’s Agência Nacional de Vigilância Sanitária; Health Canada; Japan’s Ministry of Health, Labour and Welfare; the Japanese Pharmaceuticals and Medical Devices Agency; and the FDA. Audits are conducted by auditing organizations authorized by the participating regulatory authorities to audit under MDSAP requirements.
For more information on Tasso’s blood collection solutions currently available in global markets, please visit www.tassoinc.com.
About Tasso
Tasso is an emerging healthcare technology company that is transforming the traditional blood collection paradigm with a patient-centric approach. The company’s devices enable simple, convenient, and virtually painless blood collection for users. Tasso technology has the power to bring healthcare anywhere, any time. Headquartered in Seattle, Washington, Tasso is privately held and funded by grants, investments and co-development deals with various industry leaders. For more information, please visit www.tassoinc.com.
