Arrangement for testing of medical devices

ARRANGEMENT FOR TESTING OF MEDICAL DEVICES

We arrange for and provide support in conducting technical tests, toxicity testing, electromagnetic compatibility (EMC) tests, and clinical trials of medical devices.

We monitor the entire testing process and check test results for regulatory compliance.

We cooperate only with leading laboratories whose expertise can be trusted.

ARRANGEMENT FOR TECHNICAL TESTING OF MEDICAL DEVICES

Our company provides support in technical testing of medical devices at a testing laboratory with the view to assess the conformity of their technical and operational characteristics to the requirements of regulatory documents, technical and operational documentation.

Rezultat Audit LLC is a part of the same group of companies as a technical device security testing laboratory of Electrontest LLC whose key line of business is warranty testing of medical devices for the purposes of their registration in the Russian Federation and the EAEU.

ARRANGEMENT FOR TOXICITY TESTING OF MEDICAL DEVICES

Our company provides support in toxicity testing of medical devices at a testing laboratory Electrontestbio LLC with the view to assess their biological safety.

Electrontestbio LLC is a toxicity testing laboratory that tests medical devices and medicinal drugs for biological safety. The laboratory comprises the divisions for microbiological research, chemical and sanitary research, and toxicity studies with a vivarium.

ARRANGEMENT FOR ELECTROMAGNETIC COMPATIBILITY (EMC) TESTING OF MEDICAL DEVICES

Our company provides support in electromagnetic compatibility (EMC) testing of medical devices at a testing laboratory with the view to assess their conformity to the technical documentation and state standards for electromagnetic compatibility of products.

ARRANGEMENT FOR CLINICAL TRIALS OF MEDICAL DEVICES

Our company arranges and provides support in clinical trials of medical devices at accredited sites with the view to confirm their safety and efficacy.

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