Problem Statement:
An established Indian manufacturer of medical equipment approached D2R Global Consulting to conduct comprehensive testing of their portable fetal doppler device. The client sought to ensure compliance with ISO 13485 and IEC standards for safety, performance, and quality. The testing protocols needed to cover electrical, biological, and mechanical aspects, ensuring the device met global regulatory requirements.
Our Solution:
- Conducted electrical testing, including safety and electromagnetic compatibility (EMC), as per IEC 60601-1 standards.
- Performed biological testing for biocompatibility in compliance with ISO 10993 to ensure patient safety.
- Executed mechanical testing to verify structural integrity, durability, and performance under operational conditions.
- Validated calibration, signal accuracy, and sensitivity to ensure reliable detection of fetal heart rates.
- Aligned the testing process with ISO 13485 QMS requirements and prepared detailed reports for regulatory submission.
Outcome:
The portable fetal doppler successfully met the required ISO 13485 and IEC standards, demonstrating compliance with global safety and performance requirements. The client is now equipped to market the device confidently in both domestic and international markets, leveraging its compliance credentials to expand its reach.
