Medical Device Testing
Ensuring Safe, Effective, and Compliant Medical Device Testing
Safety Testing
We ensure your medical device meets international electrical safety standards such as IEC 60601 - 1 (for general safety) and IEC 61010 (for lab equipment). This includes evaluation of leakage current, dielectric strength, mechanical hazards, and patient/operator protection. Safety testing is critical before clinical trials or regulatory submissions, and D2R helps interpret results and implement design improvements for compliance.
EMC/EMI Testing
Our EMC/EMI testing ensures your device can operate correctly in real-world environments without causing or being affected by electromagnetic interference. We test to standards like IEC 60601-1-2, checking for emissions, immunity to radiated and conducted disturbances, and electrostatic discharge. This is essential for both active implantables and patient-connected diagnostic equipment.
RF Testing
Devices using RF technologies such as Bluetooth, Zigbee, or proprietary wireless modules undergo RF exposure and spectrum performance testing. We measure parameters like transmit power, occupied bandwidth, spurious emissions, and channel stability to ensure regulatory and functional performance requirements are met under FCC, ETSI, and CDSCO norms.
Wireless Co-existence
Wireless coexistence testing evaluates how well your medical device performs in the presence of other wireless devices operating in the same frequency band. This ensures robust performance in environments like ICUs or operation theaters where multiple wireless technologies are used. We follow ANSI C63.27 to validate device resilience.
BIS Testing
For certain medical devices in India, compliance with Bureau of Indian Standards (BIS) is mandatory under the Compulsory Registration Scheme (CRS). D2R coordinates end-to-end testing, documentation, and lab selection to help clients obtain BIS registration for electronic and radiological medical equipment.
CB Testing
We assist in IECEE CB Scheme testing to allow international recognition of your product safety tests. The CB certification acts as a foundation for CE marking, BIS, and other regulatory approvals. We ensure your testing meets harmonized IEC standards and help prepare technical files for certification bodies.
FCC Compliance
Devices marketed in the US must comply with FCC Part 15 or other relevant rules for unintentional and intentional radiators. D2R helps manage pre-testing, documentation, and coordination with FCC-accredited labs. This ensures your wireless-enabled device is cleared for distribution in the US.
RED/ETSI Compliance
For the EU market, we support testing under the Radio Equipment Directive (RED) and applicable ETSI standards. Our team ensures that your device meets spectrum usage, EMC, and health and safety requirements. We guide you through documentation and Notified Body interactions when needed.
RoHS Compliance
We ensure your medical device complies with the Restriction of Hazardous Substances (RoHS) directive. This involves analyzing device components for substances like lead, mercury, cadmium, and brominated flame retardants. D2R assists with material declarations, third-party lab testing, and technical documentation for regulatory audits.