Medical Device
Testing Services
Conducting Mandatory Medical Device Testing in Compliance with Current Russian Regulatory Requirements.
50 working
days
Toxicological tests
Conducting tests in accredited laboratories for MD directly or indirectly in contact with the human body, to assess sanitary-chemical, microbiological parameters and biological safety.
Samples of the MD
Samples of a MD or accessories to the MD or medical device materials and (or) accessories materials that come in contact with the human body
Application for toxicological studies
Detailed description of all materials that come into contact with the patient, including: name, brand and manufacturer of materials and dyes; information about the type of sterilization (if applicable); type and duration of contact with the human body, in accordance with ISO 10993-1.
Technical and operational documentation
50 working days
Technical tests
Conducting tests in accredited laboratories to confirm the compliance of a medical device with the technical and operational documentation of the manufacturer, as well as the requirements of applicable standards.
Electromagnetic compatibility (EMC) tests are also carried out on all electrical products.
We select a testing laboratory taking into account applicable standards and test methods:
Import of samples
- Import of samples to Russia for testing
Expert visit to the MD installation site
- Applicable for products that require permits (licenses) for installation, creation of special conditions, construction of individual capital structures, etc.
Required documents:
- Technical and operational documentation
- Test-reports on applicable standards
- Risk management report
- Usability engineering file
- Validation and verification report for MD and software
- Essential requirements
30 working days
Clinical trials
Tests are carried out in accredited clinics in the form of research or in the form of trials, carried out to evaluate the safety and effectiveness of a medical device.
Our company’s specialists analyze available documents, conduct a literature search, analogues, etc., request additional materials from the manufacturer and prepare an Act, Program and Clinical Trial Protocol for subsequent approval by the hospital.
- Clinical trials of medical devices are conducted in the form of analysis and evaluation of clinical data.
(If MD is not a new type, and it does not use new complex and (or) unique and (or) special methods and medical technologies etc.)
- The sample of the medical device is also examined during trials.
- If the product is not imported into the territory of the Russian Federation, we will organize a specialist visit to the MD installation site (Applicable for products that require permits (licenses) for installation etc.)
Required documents:
- Technical and operational documentation
- Protocols of toxicological, technical and other tests carried out for registration;
- Documents containing data on the clinical use of a medical device, including outside the Russian Federation, including reviews, reports on scientific research, publications, reports, risk analysis of use, methods of using a medical device (if available);
Request a Consultation for Medical Device Certification and Registration
Complete our short questionnaire and receive 10% off our consultation services.