MEDICAL DEVICES TESTING LAB

Medical devices testing laboratory (ISO 17025) has been established on the basis of the IMPROVE MEDICAL LLC.

Laboratory of IMPROVE MEDICAL is the only laboratory of technical testing in Ukraine that has the opportunity to test medical devices used in modern interventional cardiology and cardiac surgery. Based on our in-depth knowledge of hydrodynamics of cardiovascular system, understanding the requirements for testing mechanical and biological heart valves prostheses and the regulatory framework, our team can assess the hydrodynamic characteristics of prostheses of surgical heart valves and test their strength in accordance with the requirements of ISO 5840 -2: 2015. In addition, the laboratory team of IMPROVE MEDICAL has extensive experience in testing of modern transcatheter prostheses of aortic and mitral valves for compliance with the requirements of the standard ISO 5840-3: 2015.


Enumeration of the range of the products which can be tested by the laboratory:

Parts and equipment for manufacture of the medical devices:

Checking of the appearance. Check of the marking, packing.
Checking of the constructional elements and their dimensions.
Chatter stability, vibration survival testing.
Shock test: impact resistance testing.
Resistance to twisting.
Leak test.
Measurement of the electrical resistance of the power core.
Measurement of the electrical resistance of the insulation.
Testing by the voltage of the alternating current and by the voltage of the direct current.
Testing for the resistance of the devices to the impact of the elevated operational temperature of the environment.
Testing for the resistance of the devices to the impact of the reduced operational temperature of the environment.
Testing for the resistance of the devices to the impact of the elevated humidity of the air.
Testing for the resistance of the devices to the impact of the special media.
Determination of resistance to pre sterilization cleaning, disinfection and sterilization.

32300    UKRAINE
Khmelnitskaya obl.
Kamyanets-Podolskiy
ul. Khmelnitskoye shosse, 38
E-mail: lab@improvemed.com.ua

Mariya Slabinskaya  

Director of the Medical devices testing laboratory
Tel.: +38044 355 5030

Our full-service medical device testing laboratory can provide you with answers to even the most complex product analysis and development questions regarding medical devices, polymers & plastics,.  Call us today at +38044355 5030 for a complimentary initial consultation with one of our Ph.D. scientists.