Medical device software - Software life cycle processes

Designation Number:
CAN/CSA-CEI/IEC 62304:14
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.

This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.
 

Project need:

To maintain alignment with international standards requirements - amendment

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Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.