Alma (Buffalo Grove, Ill.) announced that it has received the Medical Device Single Audit Program (MDSAP) certification.
ISO 13485:2016 and MDSAP are medical device industry quality standards that cover the requirements of different regulatory jurisdictions and are compliant with U.S., Canada, Australia, Brazil and Japan health authority guidelines.
“We are extremely proud of this latest achievement, which positions us at the forefront of quality assurance in the industry,” Avi Hirshnzon, EVP of quality assurance and regulation affairs at Alma, said in a press release.
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.
“Alma, as an industry leader, marks innovation, quality and safety as key corporate pillars. Obtaining the MDSAP certification is an important step to maintain our productive and successful market leadership,” Lior Dayan, CEO of Alma, said.
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