What is ISO 13485?

ISO 13485 is an international standard that defines the requirements of a Quality Management System (QMS ) for medical devices. Intended for manufacturers, suppliers and distributors, it guarantees patient safety, product quality and regulatory compliance.

Recognized worldwide, it serves as a benchmark for demonstrating compliance with legal and industrial requirements in the field of medical devices.

ISO 13485 is designed for use with any product or service you provide to the medical device industry:

• Manufacturing,
• Design,
• distribution,
• Parts supply,
• Services,
• Subcontracting activities ,
• And more...

All players in this field fall within the scope of ISO 13485 and are eligible for certification.

The number of ISO 13485 certifications is increasing worldwide.

By December 31, 2020, there were over 25,000 certificates, including around 1,000 for France.

ISO 13485 is based on a number of fundamental principles designed to ensure the quality, safety and regulatory compliance of medical devices.

These principles structure the Quality Management System (QMS ) and enable organizations to optimize their processes while meeting industry requirements.

1. Process approach
   Each activity is considered as an integrated, interdependent process. This approach ensures the consistency, efficiency and continuous improvement of the QMS by structuring complex operations into manageable processes.
2. Proactive risk management
   Identifying, assessing and controlling risks at every stage of the medical device lifecycle: design, manufacture, distribution and use.
   This approach aims to ensure product safety and efficacy, while guaranteeing compliance with regulatory requirements.
3. Customer focus
   Understand and anticipate customer needs, while complying with regulatory requirements.
   Customer satisfaction is a central element of the QMS and contributes to improving the quality of medical devices.
4. Continuous improvement
   Adopt a culture of continuous improvement at all levels of the organization.
   Applying the PDCA cycle (Plan, Do, Check, Act) optimizes the control and efficiency of processes and products.
5. Staff involvement
   Encourageactive involvement of employees in the QMS.
   Ensure their competence through appropriate training, thereby reinforcing the quality and conformity of medical devices.
6. Documentation and regulatory compliance
   Maintain rigorous documentation to demonstrate compliance with standards and facilitate audits.
   Comply with local and international requirements to access global markets.

These principles enable organizations to guarantee the quality, safety and efficacy of their medical devices, while meeting customer expectations and regulatory requirements.

The certification cycle lasts three years.

It begins with an initial audit in two stages: first a document review to verify process compliance, followed by an on-site audit to assess their application.

Once certification has been obtained, annual surveillance audits are carried out over the following two years to ensure continued compliance.

At the end of the three-year period, the process must be renewed to retain certification.

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It is essential to be independent of the certifier from the outset of your certification. It's up to the company to decide on its approach and its security program. Many auditors come from large groups, and don't have the pragmatic approach needed by small and medium-sized businesses.

That's why it's important to have the right experts at your side.