Alma, one of the top five global leaders of energy-based medical and aesthetic solutions, today announced it has received the Medical Device Single Audit Program (MDSAP) certification, following an audit process to upgrade its quality management system certifications.
The ISO 13485:2016 and MDSAP are the latest Medical Device industry quality standards, which cover the requirements of multiple regulatory jurisdictions, and comply with the guidelines of health authorities in the USA, Canada, Australia, Brazil and Japan.
The MDSAP defines medical device manufacturers” quality management system standard, as well as those for design and development, purchasing, manufacturing processes, distribution, service and post-marketing surveillance.
‘We are extremely proud of this latest achievement, which positions us at the forefront of quality assurance in the industry,’ said Avi Hirshnzon, EVP Quality Assurance & Regulation Affairs.
‘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,’ said Lior Dayan, Alma”s CEO.
Alma is a global innovator of Laser, Light-based, Radiofrequency, Plasma and Ultrasound solutions for the aesthetic and surgical markets. We enable practitioners to offer safe and effective procedures while allowing patients to benefit from state-of-the-art, clinically proven technologies and treatments.
About Sisram Medical Ltd
Sisram Medical Ltd (1696.HK), the first Israeli company to be listed on the Hong Kong Exchange Main Board, was established in 2013 for the acquisition of Alma, a leading provider of energy-based surgical and medical aesthetic solutions, ranked No. 1 in the People”s Republic of China and one of the top 5 global leaders in its industry. Sisram Medical is majority held by Fosun Pharma, a leading healthcare group in China.
Sisram Medical – Enhancing Quality of Life.
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HONG KONG, November 30, 2018 /PRNewswire/ —