Toxicity testing of medical devices


Аккредитация на регистрацию по правилам ЕАЭС

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Регистрация медицинских изделий под ключ

Technical tests involve testing to determine whether a medical device meets safety, quality and regulatory requirements when used for its intended purpose as provided for in the manufacturer’s technical and operational documentation. Technical tests are a mandatory step in the process of obtaining a Registration Certificate for a medical device.
MEDALIS can arrange technical tests of a medical device by an accredited safety testing laboratory for technical equipment run by Eleсtrontest LLC.

When technical tests of medical devices are carried out and for what purpose

Technical tests are performed in accordance with Order No. 2n of the Ministry of Health dated January 9, 2014. The Order stipulates that technical tests should be performed at the stage of compiling a registration dossier. Technical tests of a medical device should be performed by an accredited testing laboratory whose reports are recognized by the central Registration Authority, namely the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
The purpose of technical testing is to make sure that the medical device is compliant with:

  • Regulations of the Russian Federation and the EAEU rules for registration of medical devices;

  • The manufacturer’s technical and operational documentation;

  • Requirements for quality, safety and efficacy of the medical device.

MEDALIS is part of Eleсtrontest Group; therefore, we guarantee that technical tests will be carried out promptly and at a high level of quality, according to both national and EAEU regulations.

Preparation for and stages of technical tests

The process of technical testing is divided into three stages:

  • First, the laboratory determines the subject, methods, facilities and purpose of the technical tests. The contents of the submitted documentation package are identified, including the manufacturer’s technical and operational documentation along with enclosed materials, if any, and photographs. Also, the laboratory identifies regulations that will govern technical tests for the particular category of medical device. This stage ends with signing a Technical Testing Program.
  • The second stage involves a detailed study of technical characteristics of the medical device to be registered, and a simultaneous completion a Technical Testing Report. The laboratory analyzes the composition, materials and other technical characteristics of each version of the medical device being tested. Then, they perform technical tests of the medical device according to the plan established in the Technical Testing Program in accordance with the reference documentation and state standards. The outcome of the stage is a properly prepared and completed Technical Testing Report.
  • The third stage is the final one. The laboratory issues a Technical Testing Assessment Report. It summarizes information collected during the technical tests and indicates whether the medical device to be registered is compliant with the quality, safety and efficacy requirements. In addition, it confirms that the medical device meets state standards, regulatory requirements, technical and operational documentation.

What the Customer of technical tests will get

Upon completion of the technical testing, the Customer will receive all of the above documents, and in particular: Technical Testing Programs, Technical Testing Report, and Technical Testing Assessment Report. These documents, when taken together, confirm the testing results and expert conclusions regarding compliance of the subject medical device with all legal requirements for quality, safety and efficacy.

Four reasons to work with Medalis

  • We are accredited for testing medical devices under the EAEU regulations.
  • We charge no markup or hidden fees.
  • We offer a turnkey registration service, which includes technical tests, toxicity testing and clinical trials of medical devices.
  • MEDALIS LLC is part of Eleсtrontest Group which has helped obtain more than 600 Registration Certificates for various medical devices.

By hiring MEDALIS, you will get expert services with no agency fees, and consultancy support throughout the registration process of your medical device.

Please contact us by phone at: +7 (495) 455-11-16 (ext. 206) or +7 (919) 777-93-36 to start cooperating today.

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The Elecrontest Group of Companies has been operating in the medical device circulation market for more than 10 years. During its existence, more than 600 registration certificates have been successfully obtained.

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