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Certification of Quality
Management Systems
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Compliance with Quality Management Systems (QMS) requirements improves quality, reduces defect rates and ensures that the basic requirement for medical devices is to achieve benefits in excess of possible risks. To meet this requirement, medical devices must meet the criteria of quality, safety and efficiency.
Until recently the implementation of QMS by domestic manufacturers of medical devices (MD) and maintenance companies of medical equipment was voluntary. However, to date, the following regulatory documents have been developed and accepted, which establish requirements for the necessity of QMS implementation on a mandatory basis:
Until recently the implementation of QMS by domestic manufacturers of medical devices (MD) and maintenance companies of medical equipment was voluntary. However, to date, the following regulatory documents have been developed and accepted, which establish requirements for the necessity of QMS implementation on a mandatory basis:
- Decree of the Government of the Russian Federation from 09.02.2022 №135, which introduces a requirement for Russian manufacturers of MD on the need to develop and implement QMS in accordance with GOST ISO 13485-2017. The requirement is mandatory for manufacturers of sterile MD of risk class 2a and all MD of risk class 2b and 3. For other manufacturers the requirement is advisory in nature - those who have implemented and passed the QMS compliance check will be able to make changes in registration dossiers on a notification basis without conducting an examination of quality, efficiency and safety.
- Decree No. 2129 of the Government of the Russian Federation of November 30, 2021 established the necessity for organizations engaged in maintenance of MD, except for MD of risk class 1, to implement QMS in accordance with the requirements of GOST ISO 13485-2017.
- Decision of the EEC Council dated November 10, 2017. N 106 establishing the need to implement QMS for manufacturers of MDs planning to register MDs under EEU rules.
As experience shows, the absence of an implemented QMS leads to closer scrutiny by the regulator when going through registration and licensing procedures. Absence of QMS that meets the requirements of GOST ISO 13485-2017 and/or Decision No. 106 may be considered as absence of necessary conditions for carrying out the activity on production of MD / maintenance of medical equipment.
Our company provides professional assistance to manufacturers of medical devices in solving practical problems related to registration of medical devices. Having expert knowledge and vast experience in practical registration and certification of medical devices in Russia, due to successful cooperation with the largest foreign and Russian companies we have been successfully implementing projects since 2005.
Our company provides professional assistance to manufacturers of medical devices in solving practical problems related to registration of medical devices. Having expert knowledge and vast experience in practical registration and certification of medical devices in Russia, due to successful cooperation with the largest foreign and Russian companies we have been successfully implementing projects since 2005.
The success of our company is based on unchanging principles of honest and open style of doing business, high quality of work, professionalism, client orientation, responsiveness to changes in existing conditions and legislation, and most importantly, the value of human relationships. OOO "SSMK" seeks to achieve high standards at all stages of work, as evidenced by the success and volume of successfully implemented projects, the dynamics of the company and its reputation in the market. We provide a full range of services from the audit of existing manufacturer documentation and assessment of its compliance with the requirements of QMS, ISO 13485, GOST 2.114.-2016, 11n, PP RF 1416 and other regulatory requirements applicable to MD, to the registration of medical devices "turnkey".
What you get by working with us:
- Our own staff of technical, clinical and registration specialists with expert knowledge and experience in QMS confirmation, MD registration, development of documentation in accordance with QMS, norms and requirements of current legislation. Our specialists are constantly improving their knowledge through training and participation in educational conferences;
- Individual approach, which allows you to give control of most processes in our hands. Each project is assigned to a specialist, who controls all stages of work and advises on all matters relating to the services rendered;
- Wide range of services: from audit of existing documentation and comprehensive assessment of documentation readiness for the registration procedure, to preparation of the dossier on a turnkey basis. Thus, it is possible to provide both specific services (organization of tests, development of technical and operational documentation in accordance with the requirements of the QMS and current legislation), and complete preparation of the dossier for expert review;
- Long-term experience of cooperation with the largest testing and laboratory centers, medical preventive institutions, conducting technical, toxicological and clinical tests, which allows to organize all types of required tests with the least expenditure of resources;
- Reduction of registration costs, because we help you minimize your registration time, avoid re-applications, and conduct research and tests on your product on the most favorable terms;
- Direct cooperation with a translation and notary office, allowing you to carry out urgent translations during the work and to certify documents in the prescribed manner;
- Direct collaboration with an exit-testing agency (issuing visas, issuing tickets and all conditions for staying in the country of departure);
- Assistance in elimination of complicated remarks to the registration dossier, including remarks on the results of state control;
- We bring all projects to the result.
The cost of services is calculated individually and depends on the amount of work required. To calculate the cost contact us in any convenient way for you to get a free consultation.
Send us a request, our registration specialist will analyze the available data, select the optimal registration algorithm, estimate the amount of work required to prepare the dossier and send you a quote.
Application for consultation on certification and registration of medical devices
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