ISO 13485:2016 medical devices management system

ISO 13485 is a standard that defines the requirements of a quality management system for manufacturers, distributors, service and logistics companies in the medical devices industry. It is derived from the international quality management standards ISO 9001. The concept of the standard is based on the ISO 9001 process model, ie PDCA (Plan-Do-Check-Act), but mainly focuses on compliance with regulations. The purpose of the implementation and certification of the ISO 13485 standard in companies is the maximum possible unification of the quality management systems used in a given company with the requirements of the provisions on medical devices. CeCert is a certification body specializing in the field of medical devices. We have a wide group of auditors with many years of experience. We also invite you to familiarize yourself with the training offer dedicated to the area of ​​medical devices.

For whom?

  1. manufacturers of medical devices;
  2. distributors of medical devices;
  3. service companies;
  4. suppliers of critical components;
  5. manufacturers of medical equipment;

Certification benefits:

  1. increasing customer confidence in the company;
  2. having a certificate increases the trust of customers on local and international markets;
  3. better quality of the offered products;
  4. reducing the number of complaints;
  5. increasing the safety of the offered medical devices;

Selected CeCert customers:

Do you have questions or concerns?

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