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ISO 13485

Management System of

Medical Devices

ISO 13485 certification gives manufacturers and distributors the confidence that organizations can ensure and maintain compliance across the entire medical device supply chain.

ISO 13485 provides a comprehensive framework for medical device manufacturers and distributors to ensure product quality and regulatory compliance.
In a highly regulated activity such as the manufacturing and marketing of medical devices, organizations have a duty to show that each product meets both customer expectations and applicable regulations.

The PGM supports customers in their efforts to meet the stringent requirements of ISO 13485, perfecting the cycles of product development life to secure a market launch in regulatory compliance.

In order to help organizations improve their quality, PGM provides the following services:

  • Customised training;

  • Internal Audits of the Medical Device Management System;

  • Support in the implementation and certification of a Medical Device Management System ( NP EN ISO 13485 ).

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