Morrisville, NC (November 1, 2017) – 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,” said SunTech Medical President, Rob Sweitzer. “The certification assures our customers that our manufacturing practices are among the best in the world.”
For more information, call SunTech Medical at 1.800.421.8626 or visit www.suntechmed.com/.
About SunTech Medical
SunTech Medical, a Halma company, has been the preeminent supplier of clinical-grade blood pressure monitoring products and technologies for 30 years. More than 75 companies trust SunTech Medical's OEM non-invasive blood pressure solutions for their patient monitoring needs. SunTech Medical produces the leading cardiac stress test blood pressure monitor and is the world's foremost manufacturer of ambulatory blood pressure monitoring products. SunTech Medical also offers solutions for in-office blood pressure monitoring for human and veterinary markets, as well as a complete line of blood pressure cuffs designed for general and specific applications.