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Devyser receives MDSAP Certification

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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.

Fredrik Alpsten
CEO Devyser
fredrik.alpsten@devyser.com
Phone: +46 (0) 706 67 31 06

Olle Myrberg
Head of Quality Assurance Devyser
olle.myrberg@devyser.com
Phone: +46 (0) 706 20 32 14

About Devyser

Devyser is specialized in the development, manufacture and sales of diagnostic kits for complex DNA testing within oncology, hereditary diseases and transplantation. The products are used to guide targeted cancer therapies, to enable a wide array of genetic tests, as well as in post-transplant follow-up. Devyser’s product development focuses on simplifying and streamlining complex testing processes to improve throughput, reduce hands-on time and produce accurate and trusted results. Support and customer care are provided through in-house experts. Founded in 2004 and based in Stockholm, Sweden, Devyser provides genetic tests to diagnostic laboratories in over 60 countries worldwide, both through its distributor network and directly to laboratories. Find out more about Devyser at www.devyser.com and follow at LinkedIn

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regulatory Devyser IVD MDSAP

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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.
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.
Olle Myrberg, Head of Quality Assurance at Devyser.