ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:2016 standard is the internationally recognized standard for the implementation of a quality management system for medical devices and is applicable to companies that design, produce and distribute medical devices. It follows the philosophy and structure of ISO 9001 and includes requirements of the standard for good practices that must be applied during the design, production and distribution of medical devices.

PROSPERITY Ltd. provides expertise and consulting support to companies interested in the development and implementation of a quality management system based on the requirements of the ISO 13485:2016 standard.

It should be noted at this point that PROSPERITY LTD does not simply carry out studies, but provides its clients with the know-how to design, implement and maintain a quality management system for medical devices. This means in simple words that PROSPERITY LTD trains the staff of Businesses/Organizations on the requirements of the ISO 13485:2016 standard and gives them the know how to use the tools it will provide them (Manuals, procedures, forms, Instructions, applications, etc.).

Companies involved in the marketing and distribution of medical devices must meet the following requirements, which are listed in summary, in order to be certified according to ISO 13485:2016:

-  First, the company must have defined written procedures regarding the receipt, storage and

   distribution of medical devices and have appropriately trained staff.

-  The company must appoint a Person Responsible for the process of implementing the "Good Practice Guidelines".

-  In addition, it must keep records that allow the products to be traced from their purchase until their delivery to the customer. The

   retention period of the records must not be less than five years.

-  In the storage areas, the temperature/humidity conditions provided by the manufacturer of the products must be observed, while

   measures must be taken to avoid leaks or breakages.

-  During the distribution of the products, the necessary measures should be taken to ensure their integrity and to avoid their

   contamination.

-  During the implementation of the Management System the Responsible Person should inspect the degree of compliance with the

   system and record his findings.

-  For the returns of medical devices, the applicable European legislation should be observed (Article 10 of Directive 92/25/EEC).