Devyser receives MDSAP certification

Published: November 18, 2020

We’re happy to announce that we’ve received certification for the successful completion of a Quality Management System audit under the Medical Device Single Audit Program (MDSAP)!

The MDSAP is a stringent audit process that allows for a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that, in addition to ISO13485:2016, satisfies the relevant requirements of the regulatory authorities participating in the program, including those in Canada, the United States, Brazil, Australia and Japan. Read more in today’s press release, published below.

Stockholm, November 18 2020 – Devyser, Swedish molecular diagnostics company, is pleased to announce that it has received certification for the successful completion of a Quality Management System audit under the Medical Device Single Audit Program (MDSAP).

The MDSAP is a stringent audit process that allows for a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that, in addition to ISO13485:2016, satisfies the relevant requirements of the regulatory authorities participating in the program, including those in Canada, the United States, Brazil, Australia and Japan.

“Achieving the MDSAP certification confirms our ongoing commitment to maintaining the highest quality assurance standards within the In Vitro Diagnostic Medical Devices (IVD). The certification provides compliance in new jurisdictions enabling great potential for future market expansion and growth” says Fredrik Alpsten, CEO at Devyser Diagnostics AB.

“Delivering products that meet our customers’ high expectations is at the core of our business. The MDSAP certification is yet another token of this commitment, an achievement made possible by the entire Devyser staff and their unwavering focus on quality” says Olle Myrberg, Head of Quality Assurance at Devyser.

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