Are you involved in the medical device sector? ISO 13485 certification under accreditation attests 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 your customers that you are complying with regulations, taking their requirements into account, and controlling your activity and the risks associated with it. You'll be able to project an image of competence and reliability, thanks to the implementation of a demanding, recognized standard.
WHAT IS THE REGULATORY ENVIRONMENT FOR MEDICAL DEVICES?
The term "medical device" corresponds 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 moving towards a tightening; with the arrival of European Union 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 players 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 role in demonstrating regulatory conformity, which is internationally recognized by industry players.
WHO IS CONCERNED BY ISO 13485?
ISO 13485 is designed 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 players in the sector fall within the scope of ISO 13485 and can be certified.
WHY GET ISO 13485 CERTIFICATION?
This certification is a guarantee of your ability to consistently supply medical devices and services that meet customer and applicable regulatory requirements. It is awarded following an audit conducted by an auditor competent in your field of activity.
THE BENEFITS OF CERTIFICATION
You insure yourself and your partners
- Your compliance with current regulations
- Your compliance with customer requirements
- Your mastery of special processes and procedures
- Your control of business risks
- Your control over product traceability
- Mobilize your teams around a common project to optimize your organization.
Ensure the long-term future of your business
- Taking stock of your system and its suitability for industry requirements
- Ensuring that information about your activities is properly disseminated to the relevant authorities
- By giving your customers confidence through demanding, recognized certification.
INSTRUCTIONS FOR CERTIFICATION
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Preparing for the audit: You discuss with our teams how best to analyze and meet your needs.
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Audit: Your auditor interviews your teams, analyzes your practices and data in the light of the standard's requirements.
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Audit feedback: Summary presentation of audit findings, presentation of audit report.
- Certification: AFNOR Group issues your certificate and logo for 3 years
- Monitoring and renewal: A follow-up audit is scheduled every year, and a renewal audit every 3 years.
WHY CHOOSE THE AFNOR GROUP?
- The expertise of a leader with over 70,000 certified sites worldwide
- The reputation of a long-standing player in organization certification for over 20 years
- The strength of a network of 1,750 auditors and assessors dedicated to your success
- Our presence in over 100 countries makes it easy to roll out your processes worldwide
- Modular, complementary certification solutions tailored to your situation
- You have a personalized customer area to help you manage your certification, prepare your audits and track the progress of your process, as well as access your certificate and audit reports.
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