The Medical Device Single Audit Program (MDSAP) allows manufacturers to meet regulatory requirements in Canada, Australia, Brazil, Japan, and the U.S., through a single audit. TMed Technology obtained MDSAP certification in September 2024, confirming compliance with ISO 13485, the global quality management standard for medical devices. Following a successful audit, we are expanding our scope to include the design, development, manufacturing, and distribution of PAP devices, accessories, and software for both sleep therapy and diagnosis, with the updated certification expected by March/April 2025.
You can download our MDSAP certificate here.

The Medical Device Establishment License (MDEL) is required to manufacture or distribute medical devices in Canada, ensuring compliance with Health Canada's regulations. TMed Technology obtained our MDEL in June 2022, authorizing the distribution of CPAP devices nationwide. This certification reflects our commitment to meeting regulatory standards and providing safe, reliable sleep therapy solutions.

In addition to our certifications, our quality management system adheres to ISO 14971 for risk management and IEC 62304 for medical software design and development. This ensures the safety and reliability of our medical devices throughout their lifecycle.