Quality Assurance

Alma is committed to total customer satisfaction by providing consistently high quality products that meet and exceed the expectations of our worldwide 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

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