Clinical grade blood pressure device specialist SunTech Medical has successfully upgraded its ISO 13485 certification to include the Medical Device Single Audit Program (MDSAP) standard. ISO 13485 with MDSAP confirms that SunTech meets all regulatory requirements in the U.S., Canada, Brazil, Japan and Australia for medical device design and manufacturing.
Introduced in 2014, MDSAP certification requires that the recipient pass an extensive auditing process to prove its existing quality management system meets the requirements set forth by governing bodies in the U.S., Canada, Brazil, Japan and Australia for the design and manufacture of medical devices.
“We are proud to be one of the few companies who has successfully completed the MDSAP program,” SunTech Medical President Rob Sweitzer said. “The certification assures our customers that our manufacturing practices are among the best in the world.”