Posted: July 19, 2019 |
Amsino Receives MDSAP Certification, Highest Quality Standard in Medical Device Industry
Amsino’s Quality Management System is certified to fulfil latest standards for multiple regulatory jurisdictions including US, Canada, Japan, Australia and Brazil.
Pomona, CA, July 19, 2019 - Amsino Medical Group, a leading global device manufacturer, is pleased to announce that it has successfully received a certificate for conformance with ISO 13485:2016/MDSAP (Medical Device Single Audit Program).
This certificate covers multiple Amsino manufacturing, R&D and distribution facilities in the US and Asia.
MDSAP allows the conduct of a single regulatory audit of a medical device manufacturer's quality management system that covers ISO 13485:2016 as well as the requirements of participating regulatory jurisdictions which are Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA) and the United States (FDA).
MDSAP certification means that medical device manufacturer’s quality management systems meet the requirements for design and development, purchasing, manufacturing processes, distribution, service and post-marketing surveillance.
"This is a major milestone in Amsino’s quality management system and demonstrates our ongoing commitment to maintaining the highest level of quality and safety assurance standards in the industry,” said Dr. Richard Lee, Chairman and CEO, "we are very proud of our quality management team and the hard work that led to this significant accomplishment!”
About Amsino Medical Group
Established in 1993 and headquartered in the U.S., Amsino develops, manufactures and markets medical devices that help improve the safety and efficacy of patient care under a portfolio of globally recognized Amsino brands. The company operates several U.S. FDA and MDSAP qualified manufacturing, R&D, and distribution facilities globally under ISO13485:2016/MDSAP quality management system. Visit www.amsino.com for more information.