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Quality Assurance

Alma Lasers™ adheres to the highest standards for the manufacture of medical devices. Our quality assurance system is certified according to the ISO 9001:2000, ISO 13485:2003, MDD 93/42 Annex II standards, and complies with the United States Quality Systems Regulations and GMP standards.

All our medical systems comply with the requirements of the EU Medical Devices Directive. Individual products are certified and/or cleared in the countries (for example, in the United States by the FDA) where they are used.

Certificates

ISO 9001:2008 – Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by Intertek AMTAC Certification Services.

 

ISO 13485:2012 – Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by Intertek AMTAC Certification Services.

 

CAN/CSA ISO 13485: 2003 – Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by Intertek AMTAC Certification Services.

EC-Certificate – Product Category: Medical Lasers and RF Systems, MDD 93/42/EEC, Annex II. Certification by Intertek AMTAC Certification Services.

 

Quality Systems Regulations – Design Controls and GMP as required by the US FDA.

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