Request for service
Request a call
Application for medical device development service
Application for Medical Device QMS Service
Application for medical device registration service
Application for registration of medicines
Request for service of amendments to RC/RD
Request for marketing research service for MD and Pharmaceuticals
Application for technical and medical translation
The introduction of ISO 13485 is an investment in the future of a company producing medical products. It allows:
Development and implementation of ISO13485
Назад
strengthen your position and enter new markets
increase business efficiency and enhance company reputation
to improve product safety
Stages of QMS Development and Implementation
We guarantee the performance and expert assistance at each stage of the process
At the first stage, an assessment of the current state of production and existing processes is conducted. The consulting company analyzes compliance with ISO 13485 requirements, identifies gaps and risks. A work plan for QMS implementation is developed, considering the specifics of production and regulatory requirements in Russia.
Preliminary assessment and preparation
01
The second stage involves the development of the necessary QMS documentation, including:
• Quality Policy
• Quality Manual
• Procedures and instructions covering all processes of medical device manufacturing and control
All documents are created in accordance with ISO 13485 requirements and national standards.
• Quality Policy
• Quality Manual
• Procedures and instructions covering all processes of medical device manufacturing and control
All documents are created in accordance with ISO 13485 requirements and national standards.
Documentation development
02
Implementation of the developed procedures and instructions into the company's daily operations. Consultants conduct staff training to ensure understanding and proper execution of new processes. Additionally, internal audit mechanisms are established to monitor QMS compliance.
Quality management system implemented
03
Conduct a series of internal audits to assess the effectiveness of the implemented processes. They help identify inconsistencies and areas for improvement. The auditors' findings are used to develop corrective and preventive actions to address identified inconsistencies.
Conducting internal audits
04
External certification audit is being prepared. Consultants help prepare all necessary documentation and personnel. Trial audits are conducted to verify the readiness of the company for certification audit.
Preparation for certification audit
05
The final stage includes accompanying the company in the certification audit process by an accredited body. Consultants provide support during the audit, help to quickly address any comments of auditors. After successful audit, the company receives ISO 13485 certificate
Certificate Completion Tracking
06
Other Services Within 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.
m. Kropotkinskaya
Moscow, Voekhonka Street, 15
Our Medtech Business information resource on telegram. Legislative changes, market overview and science in the field of medical devices.
