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Comprehensive services for planning, development and implementation of quality management systems for manufacturers of medical devices. Order service
Consulting QMS of medical devices
Назад
GOST R ISO 13485: Standard establishing requirements for a quality management system for the production of medical devices. The main goal of the QMS is to ensure patient safety.
A quality management system (QMS) for medical devices is a set of interrelated processes, procedures and methods aimed at ensuring high quality and safety of medical devices at all stages of their life cycle - from development to disposal.
Basic elements of the QMS for medical devices
Quality policy
Formalized intention of management regarding the overall direction and objectives of the organization in the area of quality.
Quality planning
Definition of quality objectives, processes and resources needed to achieve these objectives.
Management responsibility
Definition of management roles and authorities in the area of quality.
Resource management
Ensuring the availability of necessary resources (human, financial, material) for the functioning of processes.
Product realization
Planning, management and control of processes related to the development, production, supply and servicing of medical devices.
Measurement, analysis and improvement
Systematic collection of data, analysis of results and implementation of corrective and preventive actions.
Key stages of implementation of the QMS of medical devices
We offer services for the development and implementation of the QMS of medical devices, where at each stage we guarantee careful planning, coordination of actions of all project participants and constant quality control of the work performed.
A detailed analysis of existing processes, documentation and infrastructure is carried out for compliance with the requirements of the ISO 13485 standard.
The goals of the QMS implementation are clearly formulated, for example, improving product quality, increasing production efficiency, obtaining a certificate.
A detailed implementation plan is created, including deadlines, responsible persons and the necessary resources.
The goals of the QMS implementation are clearly formulated, for example, improving product quality, increasing production efficiency, obtaining a certificate.
A detailed implementation plan is created, including deadlines, responsible persons and the necessary resources.
Analysis of the current state and planning
01
A team of specialists responsible for the implementation of the QMS is formed.
Training is conducted for all employees so that they understand the principles of the QMS and their role in its functioning.
Each employee is assigned roles and responsibilities within the QMS.
Training is conducted for all employees so that they understand the principles of the QMS and their role in its functioning.
Each employee is assigned roles and responsibilities within the QMS.
Formation of a team and training of personnel
02
The main QMS document is developed, describing its principles, goals and processes.
Detailed procedures are created for all key processes, such as document management, change control, non-conformity management, etc.
Necessary forms and templates for documentation are developed.
Detailed procedures are created for all key processes, such as document management, change control, non-conformity management, etc.
Necessary forms and templates for documentation are developed.
Documentation development
03
The QMS is implemented in a small production area or for a specific product.
After successful completion of the pilot project, the QMS is gradually implemented throughout the entire production.
Processes are regularly monitored to identify deviations and take corrective actions.
After successful completion of the pilot project, the QMS is gradually implemented throughout the entire production.
Processes are regularly monitored to identify deviations and take corrective actions.
Process implementation
04
An internal audit plan is developed and checks are carried out to ensure that the QMS meets the established requirements.
Audit results are analyzed and corrective actions are developed.
Audit results are analyzed and corrective actions are developed.
Internal audits
05
An independent certification body accredited to conduct certification audits is selected.
A certificate of conformity is issued upon successful completion of the audit.
A certificate of conformity is issued upon successful completion of the audit.
Certification
06
Data on product quality, process efficiency, and customer satisfaction are regularly analyzed.
Measures are developed and implemented to improve the QMS. Obtaining a certificate: Upon successful completion of the audit, a certificate of conformity is issued.
Measures are developed and implemented to improve the QMS. Obtaining a certificate: Upon successful completion of the audit, a certificate of conformity is issued.
Continuous improvement
07
Наши возможности и компетенции
Highly qualified staff with professional education
The company’s staff is composed of specialists with a professional education in chemistry, biology, chemical technology, biotechnology, microbiology, biochemistry and biomedical engineering.
Cooperation with relevant organizations
We cooperate with leading medical universities, medical organizations and manufacturing enterprises to maximize the use of knowledge and experience in the medical field.
Unique automated techniques using artificial intelligence
The company uses unique, automated methods of developing documentation using artificial intelligence technologies. This improves efficiency and quality of work, as well as allows to optimize costs.
Reliable data protection
The company uses a reliable server for data storage, which provides high level of security and important information preservation.
Continuous monitoring and improvement of the process
We are not standing still and constantly optimizing the process, introducing innovations and modern approaches to the medical device design process
Leave this process to the professionals
The QMS implementation is a complex process that requires all employees of the organization to participate and management to coordinate the process.
Services within the framework of QMS consulting
RZN Expert provides services for QMS analysis and implementation in compliance with ISO 13485 requirements for medical devices. We conduct an in-depth assessment of your processes, identify vulnerabilities, and develop tailored solutions for improvement.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
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Moscow, Voekhonka Street, 15
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