Technical tests
They are carried out to confirm the product’s compliance with the declared technical characteristics, safety requirements and performance indicators.
Why choose us
Test site network sitesWe select an accredited laboratory or medical organization taking into account the product, timing and objectives of the project.
Optimal conditionsWe help you choose a profitable test format without compromising quality and legal requirements.
Process controlWe support interaction with testing centers, We monitor deadlines and receipt of official protocols.
Tests as the basis of the registration dossier
Testing is a mandatory stage of state registration of most medical products. Their results confirm the safety, quality and effectiveness of the products, and the resulting protocols are included in the registration dossier.
We organize technical, toxicological, clinical tests, as well as electromagnetic compatibility (EMC) tests in specialized accredited testing laboratories and medical organizations. Our specialists determine the required scope of research, select the optimal testing site, accompany the process at all stages and monitor the receipt of official test reports.
What is included in the service
We provide comprehensive support for testing, including:
- analysis of a medical device and determining the required scope of testing;
- determining the list of mandatory studies in accordance with current legal requirements;
- selecting a specialized accredited testing laboratory or medical organization;
- preparing a set of documents for testing;
- organizing the transfer of samples of a medical device;
- supporting technical tests;
- organization of toxicological studies;
- support of clinical trials (if necessary);
- organization of electromagnetic compatibility (EMC) tests for medical equipment, if their implementation is required by regulatory requirements;
- interaction with testing centers at all stages;
- control of work deadlines;
- receipt and verification of test reports for further inclusion in the registration dossier
What tests may be required
The list of tests is determined individually for each medical device depending on its purpose, design, class of potential risk and requirements of current legislation.
Toxicological studies
Allows you to assess the biological safety of materials in contact with the human body.
Clinical trials
Necessary to confirm the safety and effectiveness of the medical device in accordance with its intended purpose.
EMC tests
Conducted for medical equipment with electrical or electronic components and confirms immunity to electromagnetic interference.
Result
As a result of the provision of the service, you receive a full set of protocols for technical, toxicological, clinical tests and electromagnetic compatibility tests (if necessary), drawn up in accordance with legal requirements and ready for inclusion in the registration dossier.
Comprehensive support allows you to reduce the time required for preparing documents, avoid organizational difficulties and successfully pass the next stage of state registration of a medical device.
