SKM’s quality system is certified to ISO13485:2016 Medical Devices standard.
In the last decade we are focused on development and manufacturing of non-invasive medical devices for the medical industry.
We utilize our manufacturing experience mainly to embed electronic PCB units and flexible RF antennas into customized molded silicone skins and casings. In addition, we design and manufacture customized disposable end-units for surgical instruments, diagnostics equipment, healthcare and medical beauty. Our high-performance silicones comply with section 21 CFR177.2600 of the FDA regulations and with the test requirements of the ASTM D2000 standards.