From our early days, we have been at the forefront of medical and aesthetics technologies, carrying the torch of revolution in various arenas around the world, Alma is spread out in over 90 countries worldwide determined to become a market leader. Throughout 20 years of operation, our products and technologies have become globally recognized brand names and are considered the gold standard around the world. Alma has Worldwide recognized technologies and brand names:
UniPolar, SHR, ClearLift, FemiLift and Soprano. R&D – Solid pillars for our success
Research and Development have always been our core base and DNA.
16% of our employees are R&D specialists, 25% of which holds phD and advanced degrees. This approach has served as a solid base from which we lead the industry with the shortest time to market: 1-2 years vs. the 3-4 year industry standard. Today, we are a world-leading provider of energy-based solutions for the surgical, medical aesthetics and beauty markets, delivering cutting-edge technologies to our partners and customers. Alma Lasers™ quality system MDSAP and ISO 13485:2016 certified supporting the philosophy and mission to continuously provide the highest quality. Alma Lasers™ Medical devices carry the CE marking according to Medical Device Directive (93/42/EEC). Alma Lasers™ Medical devices comply with the specific local regulations and standards of the countries in which they are offered for sale. In the US market, Alma Lasers™ Medical products have FDA clearances and appropriate listing. 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. Certificates:
ISO 13485:2016 – NF EN ISO 13485:2016 – Design, manufacture, test, sale and service of medical devices. MDSAP – Design, manufacture, distribution and servicing of medical devices. Australia: Therapeutic Goods (medical Devices) Regulations, 2002, Schedule 3 Part 1
(excluding Part 1.6) – Full Quality Assurance Procedure
Brazil : RDC ANVISA n. 13/2013
RDC ANVISA n. 23/2012
RDC ANVISA n. 67/2009
Canada: Medical Devices Regulations – Pat 1 – SOR 98/282
Japan: MHLW MO 169 PMD Act
