Quality management systems

By implementing a quality management system, the companies offer confidence and guarantees to their customers and suppliers, as well as allowing them to demonstrate compliance with regulatory and legal requirements.

We develop and implement quality management systems in accordance with the standards:

  • ISO 13485. Quality management system. Medical device.
  • IISO 9001. Quality management system.
  • ISO 15189. Clinical laboratories. Particular requirements for quality and competence.
  • FDA: 21CFR820. Quality System regulation.

We are qualified auditors for the review and audit of  quality management systems.

Medical Devices

Quality Management Systems

Training

Biocides

Food and Nutritional Supplements

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Consultancy specialized in medical devicess, biocides and food and nutritional supplements.

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