Quality management system PN-EN ISO 13485:2016

  Objective: The quality of medical devices must be supervised both during the design process, production, and post-marketing.

  For whom: The European and national requirements oblige designers, producers, clinics, healthcare centers etc. to implement the certified quality management system in accordance with international requirements of ISO standards.

The introduction of the certified management system provides the user of the medical device, the patient or the medical staff that the products meet all safety requirements during use, while the manufacturer is sure that its products are of high quality, produced in accordance with applicable laws and that they are safe from the initial concept to the implementation and the supervision after the delivery.

  Procedure of ISO 13485 implementation:

Stages of the implementation of the Quality Management System ISO 13485: 2016:

• Analysis of the existing management system of the organization against the requirements of ISO 13485 (pre-audit);
• Risk analysis of the medical device to determine the scope of the ISO 13485: 2016;
• Developing a schedule of the implementation of the system;
• Developing the quality policy, objectives and strategy;
• Development of system documentation:
  • Maps of processes,
  • Procedures, instructions, forms;
• Implementation of the system procedures:
• Training for your employees on the applicable procedures and requirements of the standard;
• Internal audit;
• Management review;
• Selection of a certification body;
• Participation in external audit (on request);
• Implementation of corrective actions (if necessary).

  Benefits:​

• Opening of new distribution channels (pharmacies)
• Building the confidence in the brand of the product as a medical device.
• The certified management system contributes to the effectiveness and the efficiency of the company and increases its value through effective management.

  The time to deliver the service depends on the complexity of the product:

• Type (eg. mechanical, electrical, etc.)
• Class (I, IIa, IIb .III)