- CE certificate recognition:
The designated Certification and conformity assessment body IMPROVE MEDICAL have signed agreements with all top European Notified Bodies on the recognition of the conformity assessment results that are accredited and approved in accordance with relevant EU Directives. Notified Bodies work in all countries of the European Union, its partner countries and in many countries of the world.
Improve Medical continues preprocessing of the signing contracts with other top European Notified Bodies. These agreements allow for Improve Medical customers the opportunity to reduce technical barriers in the process of medical devices legalization in Ukraine for compliance with the technical regulations.
The signing of recognition agreements is regulated by art.45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”. In particular, Ukrainian conformity assessment body, on the basis of a document of compliance issued by a foreign notified body, applies the conformity assessment procedure or a part of it, and issues Ukrainian Certificate of conformity on its own responsibility.
- Medical devices testing lab
Medical devices testing laboratory (ISO 17025) has been established on the basis of the IMPROVE MEDICAL LLC.
Certificate №2Н1388 (June 1, 2016)
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.