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What Canadian health standards/guidelines does Stethophone AI comply with?
Only licensed medical devices can enter the Canadian market. Health Canada has licensed Stethophone and confirmed it meets the regulatory requirements for safety, cybersecurity, and effectiveness. After receiving the regulatory go ahead, we adhere to post-market surveillance requirements.
Stethophone is developed and maintained in conformity with many international and Canadian standards, guidelines, and requirements to ensure that our medical device delivers the best user experience.