Devyser receives MDSAP Certification
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. "