ISO 13485 (Medical devices)

Is your business in the medical equipment sector? ISO 13485 accreditation is irrefutable proof that your services are of the highest quality, in line with regulatory standards and the expectations of your customers and employees! This certification is a guarantee of regulatory compliance, attention to your customers’ needs, and control of your operations and related hazards. It gives you a reputation for competence and reliability, thanks to the adoption of a rigorous and recognized standards framework.

ISO 13485 (Dispositifs médicaux)

ISO 13485 is a voluntary, quality-oriented certification framework specially developed for the medical equipment industry. Bearing the title ” Medical devices – Quality management systems – Requirements for regulatory purposes “, it provides proof of compliance with regulations, and is recognized worldwide by professionals in the field.

ISO 13485 provides a solid foundation for manufacturers to comply with regulations and obligations, while affirming their commitment to safety and quality. As the benchmark for quality management systems, it is not limited to any particular piece of equipment, but encompasses the procedures essential to the manufacture of medical devices and related services.

For medical equipment manufacturers, the legality of market access for their products is crucial. National legislation generally requires ISO 13485 as part of the validation process for medical equipment.

Why choose ISO 13485 certification?

ISO 13485 certification attests to your ability to consistently supply medical equipment and services that meet consumer needs and applicable regulations. It is awarded after an audit by an auditor qualified in your field of activity.

Certification ensures that you and your partners :

The long-term future of your business is assured

  • Through an in-depth analysis of your system and its alignment with industry standards.
  • Through effective communication of information about your operations to regulatory authorities.
  • By gaining your customers’ trust through rigorous, highly-regarded certification.

What are the advantages of ISO 13485 certification?

ISO 13485 certification is advantageous for any manufacturer, but it is particularly useful for companies wishing to enter the medical equipment market.

Certified organizations can :

  • Expand their potential to win contracts with larger entities;
  • Optimize their internal procedures and decision-making processes;
  • Establish a culture of continuous improvement;
  • Affirm their commitment to quality and safety;
  • Validate their ability to meet customer demands and legal requirements.