Facilitation for Testing and Standardisation of Medical Devices

BIRAC has collaborated with Kalam Institute of Health Technology, KIHT to facilitate Start –ups, Entrepreneurs, Researchers, Academicians, Incubation Centres, SMEs etc in Testing and Standardisation of Medical Devices.

KIHT has empanelled a set of Laboratories which helps in testing to comply with applicable standards like

• Electromagnetic Interference (IEC 60601 series)
• Electromagnetic Compatibility (IEC 60601-1-2 series)
• Electrical safety testing
• Biocompatibility (ISO 10993)
• Good Manufacturing Practices (ISO 13485)
• Software testing (IEC 62304)
• Material testing (Relevant ASTM Standards)
• Radiation protection (IEC 60601-1-3)

In addition Rapid Prototyping, Health technology Assessment services are also available. If required, start-ups may also apply for voluntary NIPUN certificate.

The cost of tests varies depending on parameters, duration of testing, testing chamber configurations and number of units required to be tested. The testing charges are subsidised for BIRAC referred Start-ups to an extent of 40%-70%.

For further details please click here.

For getting reference through BIRAC and availing the subsidised cost, e-request may be sent to Sonia Gandhi, Senior Manager – Investments, BIRAC at sgandhi.birac@nic.in.

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