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|LASEROPTEK Acquired MDSAP Certification||Laseroptek||2018.08.03|
LASEROPTEK acquired MDSAP certificate on June 27, 2018. The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple regulatory jurisdictions.
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
LASEROPTEK is the first and only certified Korea laser manufacturer, indicating that LASEROPTEK retains the top-quality management system. By obtaining this certificate, LASEROPTEK anticipate to expedite overall regulatory processes in relevant countries.
International partners that are participating in the MDSAP include health authorities in USA, Canada, Australia, Brazil, and Japan.