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ISO 13485 certification - Quality management system for medical devices

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Do you work in the field of medical devices? ISO 13485 certification under accreditation attests to the fact that you provide a quality service that complies with regulations and the requirements of your customers and partners!

ISO 13485 certification helps you to guarantee to your customers that you comply with regulations, that you take their requirements into account, and that you control your activity and the risks associated with it. You thus display an image of competence and seriousness thanks to the implementation of a demanding and recognised reference system. The image of AFAQ certification enhances your efforts in relation to your market.

WHAT IS THE REGULATORY CONTEXT FOR THE MEDICAL DEVICES SECTOR?

The term "medical device" covers thousands of different products, ranging from the simplest (e.g. toothbrush) to the most complex (e.g. connected prosthesis). The regulatory framework of the sector is moving towards a tightening; with the arrival of EU Regulations 2017/745 and 2017/746, manufacturers must demonstrate their control of risk throughout the life cycle of the medical device. To do this, manufacturers and all other actors in the sector can rely on ISO 13485.

WHAT IS ISO 13485?

ISO 13485 is a voluntary quality certification standard developed for the medical devices sector. Its full title "Medical devices - Quality management systems - Requirements for regulatory purposes" indicates its character as a demonstration of regulatory compliance, internationally recognised by the industry.

WHO IS AFFECTED BY ISO 13485?

ISO 13485 was built to be used regardless of the products or services you provide for the medical device sector.

Not only production, but also design, distribution, parts supply, services and subcontracting... all the players in the sector are covered by ISO 13485 and can be certified.

WHY GET ISO 13485 CERTIFICATION?

This certification is a guarantee of your ability to consistently provide medical devices and services that meet customer and applicable regulatory requirements. It is awarded to you following an audit conducted by an auditor competent in your field of activity.

THE BENEFITS OF THIS CERTIFICATION

You insure yourself and your partners

  • Your compliance with the regulations in force
  • Your compliance with your customers' requirements
  • Your control of your special processes and procedures
  • Your control of the risks of your activity
  • Your control of the traceability of your products
  • Mobilise your teams around a common project to optimise your organisation

You ensure the sustainability of your business

  • Taking stock of your system and its suitability for the sector
  • Ensuring that information about your activities is properly disseminated to the relevant authorities
  • Giving your customers confidence through a demanding and recognised certification

INSTRUCTIONS FOR CERTIFICATION

  1. Preparation of the audit: You discuss with our teams to analyse and respond to your needs
  2. Audit: Your auditor interviews your teams, analyses your practices and your data in relation to the requirements of the standard.
  3. Restitution of the audit: Summary presentation of the conclusions of the audit, presentation of the audit report.
  4. Certification: The AFNOR Group issues your certificate and logo for 3 years
  5. Monitoring and renewal: A follow-up audit is planned every year and a renewal audit every 3 years

WHY CHOOSE THE AFNOR GROUP?

  • The expertise of the French leader with more than 70,000 certified sites in France and abroad;
  • The reputation of a historical actor in the field of certification of organisations for more than 20 years;
  • The strength of a network with 1,750 auditors and evaluators at your service.
  • Our presence in more than 100 countries makes it easy for you to do business on a global scale;
  • Complementary certification solutions that are modular and adapted to your situation;
  • You have a personalised client area to facilitate the management of your certification, the preparation of your audits and to monitor the progress of your process, access your certificate and your audit reports.

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