ISO 13485 for medical devices

The protection of medical staff in the health sector with regard to biological risks has always been one of the major subjects of the development of medical devices, particularly after the appearance of covid 19. However, manufacturers of medical devices must identify and assess biological risks, in order to prove risk control throughout the life cycle of the medical device based on ISO 13485.

The ISO 13485 standard “Medical devices – Quality management systems – Requirements for regulatory purposes” is a certification of the quality approach developed for the medical device sector. It is used to demonstrate regulatory compliance, recognized internationally by players in the medical sector.

This standard has come in favor of all players in the medical sector: products or services provided in the medical device sector such as production, design, distribution, parts provision activities or subcontracting, etc.

The management system certification under accreditation n° 4-0571 is a guarantee of the ability to regularly provide medical devices and services that meet customer requirements and applicable regulatory requirements. It is issued following an audit conducted by a competent auditor in the field of activity concerned.

The beneficiary of ISO 13485 and its partners are guaranteed:

  • Compliance with the regulations in force.
  • Compliance with customer requirements.
  • The control of its processes, special procedures and the risks of its activity.
  • Its control of the traceability of its products.
  • To mobilize its teams around the common project to optimize its organization.

The beneficiary of ISO 13485 also guarantees the sustainability of its activity:

  • By making an inventory of its system and its adequacy to the requirements of the sector.
  • By ensuring the adequate dissemination of information relating to its activities to the competent authorities.
  • By giving confidence to its customers thanks to a demanding and recognized certification.
  • By adopting a structuring approach to continuous improvement.

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