Implementation of the Quality Management System

Audit, implementation and modernization of the QMS according to ISO 13485, ISO 14971, ISO 9001

In accordance with the requirements of the Eurasian Economic Union (EAEU), manufacturers of sterile medical devices, medical devices of risk classes 2b and 3 are required to implement and maintain the Quality Management System (QMS) of medical devices in accordance with the “Requirements for the Implementation, Maintenance and Evaluation of the Quality Management System of Medical Devices Depending On the Potential Risk of Their Application”, approved by the Decision of the Council of the Eurasian Economic Commission of November 10, 2017 N 106.

Our company is the only one in Russia that conducts a pre-inspection audit of MD production for the purpose of preparation for the inspection by authorized bodies within the framework of registration of medical devices according to the rules of the EAEU.

Operation Steps

Implementation and modernization of the QMS in accordance with the requirements of GOST ISO 13485, GOST ISO 14971, GOST ISO 9001

  • Development of the QMS implementation program

  • Identification of processes, development of criteria and methods for evaluating their effectiveness and the interprocess communication diagram

  • Developing a responsibility matrix

  • Creating the document structure

  • Development and examination of QMS documents

  • Preparing the QMS

Подготовка к сертификации СМК

  • Pre-certification audit of the QMS

  • Selection of the certification body

  • Preparation and submission of an application for QMS certification to the certification body

Audit of the quality management system

Assessment of the quality management system in the production of medical devices

Maintaining and improving the QMS

In the current conditions of severe competition in the market of medical products, the implementation of a quality management system (QMS) of medical devices by the manufacturer, especially in accordance with the specialized standard GOST ISO 13485 “Medical devices. Quality management systems. Requirements for regulatory purposes”, is a significant competitive advantage, indicating the manufacturer’s objective to produce medical devices under controlled conditions, in compliance with all applicable requirements and taking into account the requirements of consumers.

Description and optimization of existing business processes

  • Reducing the cost of medical devices manufacturing through more efficient allocation of internal resources, a clear assignment of responsibility and distribution of employees’ powers

  • A competent organization of the company’s business processes from products manufacturing to the organization of the supply chain

  • Ability to enter international markets

Organization of specialized training seminars on QMS

Organization of specialized training seminars

The Fronika Group company employs only certified managers of registration of medical devices

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