Organization of clinical trials of medical devices
We organize and support clinical trials of medical devices at accredited clinical sites to confirm the safety and effectiveness of the medical device.
Organization of electromagnetic compatibility (EMC) testing of medical devices
We support EMC testing of medical devices in testing laboratories in order to assess compliance with the technical documentation and applicable national standards for electromagnetic compatibility.
Organization of toxicological studies of medical devices
We support toxicological studies of medical devices at the ElectrontestBio LLC testing laboratory in order to assess the biological safety of the device.
ElectrontestBio LLC is a toxicology testing laboratory that performs biological-safety testing of medical devices and medicinal products. The laboratory includes microbiological, sanitary-chemical and toxicological testing units, together with a vivarium.
Organization of technical testing of medical devices
We support technical testing of medical devices in testing laboratories in order to assess whether the device’s technical and operating characteristics comply with applicable regulatory documentation and the manufacturer’s technical and operating documentation.
Resultat-Audit LLC is part of the same group of companies as Electrontest LLC, a safety testing laboratory for technical equipment whose primary area of activity is acceptance technical testing of medical devices for registration in the Russian Federation and the EAEU.
Medical device testing
We organize and support technical testing, toxicological studies, electromagnetic compatibility testing and clinical trials of medical devices.
We oversee the entire testing process and verify that the resulting study/test reports comply with applicable regulatory requirements.
We cooperate only with leading laboratories whose expertise we trust.
Organization of testing of medical devices
Technical and operating documentation development services
- Development, improvement and revision of technical documentation for state registration of a medical device, including extracts from the Technical File and Technical Specifications.
- Development, improvement and revision of operating documentation for state registration of a medical device, including operating manuals and instructions for use.
- Development, improvement and revision of the medical-device risk management file, including assessment and analysis of risks at each stage of the device life cycle.
- Development, improvement and revision of reports required for medical-device registration.
- Preparation of informational and explanatory letters required for medical-device registration.
- Improvement and revision of documentation following a refusal of medical-device registration where the original submission was made independently or by another consulting provider.
What is this service?
We provide standalone support for developing and improving technical and operating documentation for subsequent medical-device registration.
High-quality technical and operating documentation that complies with regulatory requirements is one of the most important sources of information about a medical device.
This service is particularly valuable for manufacturers that register medical devices independently but do not have sufficient experience developing individual regulatory documents.
Errors in documentation submitted to Roszdravnadzor can lead to a large number of registration refusals and substantial financial and time losses. Our task is therefore to develop documentation of the highest possible quality that complies with all applicable regulatory requirements.
Documentation development and organization of medical device testing
Companies
Services for obtaining medical device Registration Certificates and preparing medical device documentation. We work in accordance with EAEU rules and Roszdravnadzor requirements.
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