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Medical Devices - ISO 13485

It is the certification Management System for Medical Devices.

It is the best for all health professions.

It refers to all the requirements of ISO 9001 standard with few exceptions by supplementing or clarifying specific requirements such as:

  1. Compliance with statutory and regulatory requirements and particularly with the European Directives;
  2. Maintenance;
  3. Work Environment (hygiene, cleanliness, contamination);
  4. Risk analysis;
  5. Design Validation;
  6. Traceability and relevant records (archiving duration);
  7. Medical Devices vigilance and product recalls.

Documented procedures or instructions are mandatory for some requirements of the standard.

 Why?

ISO 13485 is the only medical standard subject to certification. It is based on risk analysis.

ISO 13485 certification allows you to control your documentation and records. Thus, during incidents, major or minor, you can provide all the necessary evidence.

You are guaranteed to have identified and controlled each of your specific risks and to comply with applicable regulations.

You constantly improve your system and satisfy your clients.

 Why AB CERTIFICATION is the Only one who can respond to your needs?

AB CERTIFICATION:

  • is one among the rare French Bodies specialized in the health professions;
  • is ISO 9001 and 13485 COFRAC accredited, The scope of our accreditation is communicated on demand or could be checked on the COFRAC website COFRAC. This implies a European and international recognition of such certificates;
  • has over 10 years of experience in the medical activity and in the CE marking of Medical Devices (see: CE Marking);
  • is a human-sized Certification Body;
  • ensures personal contact, rapid response, better listening and customized follow-up by the same contact, specialist in the medical field.

 Quotation

Interested in certification? Please fill the following form and send it back to us by email.

Client Information Form

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