Test laboratory SibNIIICMT has been operating since 1991 and is a key unit. During its work, the laboratory has tested more than 500 samples of medical equipment. Every year 25 tests of medical products are conducted on an average, which covers the existing need for these services from organizations of the medical industry of the Siberian Federal District (based on Roszdravnadzor data).
In the subdivisions of the complex there are 11 specialists who have a basic basic education and experience in the field of technical testing of various types of medical products. The laboratory is equipped, or is able to legally use the necessary test and test equipment.
To conduct practical work on expert assessment and testing of medical equipment in SibNIIICMT there are specialized units:
- Department of scientific and technical expertise and standardization (including the fund of standards and technical conditions);
- Test laboratory of medical equipment (accreditation certificate ROSS RU.0001.22IM18).
Long-term experience has shown that it is profitable for the enterprises-developers and manufacturers of medical products to contact us at the earliest possible stage of developing or developing a serial production of products.
On orders of developers and manufacturers, we carry out the following types of work:
- scientific and technical expertise and determination of the adequacy of the requirements to the product, depending on its purpose;
- consulting on the standardization of medical devices;
- search and selection of the necessary regulatory documentation for the product;
- preparation of company documents for state registration of the medical device;
- development of draft technical conditions;
- development of operational documentation projects;
- development of documents for making changes in technical specifications and ED;
- technical assistance in improving the quality of products, the stability of basic characteristics and safety indicators;
- input control of the accessories included in the medical device;
- development of test programs at any stage of development and testing;
- development of test procedures for basic technical characteristics;
- design, qualification, periodic, sample and other types of tests;
- testing for voluntary certification;
- testing of safety indicators of medical products for compliance with general and specific safety requirements;
- tests on the resistance of products to mechanical and climatic influences;
- arbitration tests on an accredited test base;
- the organization of special types of tests at the test facilities of other enterprises;
- assessment of the risk analysis during the development or production of a medical device.
In SibNIITSMT at your service:
- highly qualified specialists in the field of examination and testing of medical devices;
- the testing base, equipped in accordance with national standards of Russia;
- complete information on the methods and results of peer review and instrumental studies of the submitted product;
- modern communication technologies, allowing to react quickly to the questions arising in the course of teamwork;
- the most complete information fund of standards for medical products;
- a wide field of accreditation, allowing to test more than twenty groups of medical products.