Our quality control system: 40 years of expertise and mutual respect
With over 40 years in the industrial sector, and over 25 years in the medical sector, Maatel’s procedures and products are subject to thorough quality control.
Our quality control system has ISO 9001 certification, and our specific medical quality control system has ISO 13 485 certification.
We meet the EN 60601-1 and derivatives standard, general safety requirements, essential electrical medical equipment performance criteria, as well as the EN 62304 standard for medical device software, life cycle software processes.
All other quality standards and regulatory requirements are applied to complement the EN 13 485 and ISO 9001 standards. For example, the Maatel team has already acquired the expertise for quality and document processes required by FDA regulations for medical products sold in the United States.
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