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Results

Certification ISO 13485 - Medical devices

You are involved in the sector of medical devices: ISO 13485 certification under accreditation proves that you provide a high quality service, in compliance with regulations and the requirements of your customers and business associates.

ISO 13485 certification helps you to ensure your customers that you comply with regulations, that their requirements are taken into account, and that your activity and the associated risks are under control.
You display an image of competence and professionalism through the implementation of a demanding and recognised standard. 

Certified companies share their feedback

Oleg Levchenko

Oleg Levchenko

Quality Manager - MSM Medimpex

“Having the official certificate gives us a competitive edge in the market, because it is recognized proof of the quality of our production.”

Axel Dubois

Axel Dubois

CEO – SLS FRANCE

…it allows us to ensure the utmost safety for the patient, thanks to carefully controlled and managed processes.”

What is the regulatory context of the medical device industry ?

The term "medical device" refers to thousands of different products, ranging from the simplest (e.g. toothbrush) to the most complex (e.g. connected prosthesis). The regulatory framework for the sector is becoming stricter; with the arrival of European Union Regulations 2017/745 and 2017/746, manufacturers must demonstrate risk management throughout the life cycle of the medical device. To do this, manufacturers and all other stakeholders in the medical device industry can rely on ISO 13485.

What is ISO 13485 ?


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

Who is addressed by ISO 13485 ?

ISO 13485 has been built to be used for any product or service provided by you to the medical device industry; production, but also design, distribution, provision of parts, services, or subcontracting... all stakeholders in the industry fall within the scope of ISO 13485 and can be certified.

Why should I get ISO 13485certified ?

This accredited certification is a demonstration of your ability to consistently provide medical devices and services that meet customer and applicable regulatory requirements. It is issued after an audit conducted by an auditor who is competent in your particular sector of activity.

Advantages of the certification

You insure yourself and your partners

  • Your compliance with applicable regulations
  • Your compliance with your customers' requirements
  • Mastering your special processes and processes
  • Your control of the risks of your activity
  • Mastering the traceability of your products
  • Mobilize your teams around the joint project to optimize your organization

Ensure the sustainability of your business

  • By taking stock of your system and its adequacy to industry requirements
  • Ensuring the proper dissemination of information about your activities to the competent authorities
  • By giving your customers confidence through a demanding and recognized certification
  • By adopting a structural approach to continuous improvement

How obtain the certification ?

1 Assessment visit

Pre-diagnosis to understand the principles of the audit and maximize your chances of obtaining certification

Find out more
2 Audit

Your auditor interviews your teams and analyzes your practices and data with regard to the requirements of the standard

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3 Audit results

Presentation summarizing the audit findings and delivery of the audit report

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4 Certification

AFNOR Certification grants your certificate and logo for three years

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5 Follow-up and renewal

A monitoring audit is carried out each year and a renewal audit every three years

Find out more

Why AFNOR Group?

  • The expertise of France’s leader in the sector, with more than 70,000 sites certified in France and abroad
  • The renown of a well-established certification leader with extensive experience in certifying organizations over the past 20 years
  • A strong network of 1750 auditors and assessors supporting your success
  • Multi-site certification management and presence un more than 100 centuries around the world

  • The proximity of our regional antennas and our presence in more than 100 countries facilitate the deployment of your initiatives around the world
  • Additional certification solutions that are modular and adapted to your situation
  • You have access to a personalized customer area to easily manage your certification, prepare your audits, track the progress of your actions, and access your certificate and audit reports.

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