ISO 13485 – the quality standard for the production of medical devices

ISO 13485 standard applies to all companies involved in one or more stages of the life cycle of medical devices such as:
• Design and development
• Production
• Storage and distribution
• Installation and service
• Withdrawal
• Design, development or provision of support services such as technical support
The standard requires several written procedures and have requirements such as:
• Application of risk based approach to all company processes and not only to productive ones
• Keeping a file for each medical device that contains the product specifications and its requirements regarding the quality management system and relevant legislation.
• Defining a specific time period for keeping the quality system records
• Defining written procedures for several topics such as
• The maintenance of the facilities where the requirements must be defined, the frequency of control and the keeping of the respective records must be foreseen.
• The working environment which includes the requirements for the staff, the working conditions as well as the corresponding controls that must be carried out by keeping the respective records.
• The sterilization of products
• The technical support related to the product
• Determining the stage of clinical trials in the design and development of new products as defined by current legislation.
• Traceability of the product which should include all the stages from the receipt of the raw materials to the final recipient of the products by keeping the relevant records.
PRIORITY has extensive experience in the development of management systems in this field. Its experienced consultants can lead you to develop of a management system according to ISO 13485 standard quickly and effectively taking into account the specifics requirements and needs of the company.

Do you want to discuss about your needs and provide you the right solutions?

BSc in Computer Science, University of Crete, and MSc in International Marketing, University of London. She is experienced in auditing Management Systems and has been working for more than a decade in international group of companies, specializing in the sector of Sales, Marketing and Corporate Communication.
Lilly Mylona
Sales, Director

Contact with

Mrs. Lily Mylona,

Sales Director, PRIORITY

[email protected]

T. 210 2509900