Health Canada Medical Device Software Validation

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Guidance Document: Software as a Medical Device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html

2.1 What is Software as a Medical Device (SaMD) - inclusion criteriaHealth Canada uses the definition developed by the International Medical Devic…2.2 Exclusion criteriaThe medical purposes described in the device definition of the Act can … See more

Guidance Document: Software as a Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html

Example 3: Software that provides a diabetic patient with simple tools to organize and track their health information. The healthcare professional can input …

Guidance Document: Guidance on supporting evidence …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-supporting-evidence-provided-new-amended-licence-applications-class-class-medical-devices-including-vitro-diagnostic.html

Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices was developed …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Draft Guidance Document: Applications for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/consulation-draft-investigational-testing-authorizations-guidance.html

The manufacturer and the importer of a medical device are required to report to Health Canada incidents that fall under the scope of section 59 of the …

Guidance Document: Pre-market …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity/document.html

The Food and Drugs Act sets out the legislative framework under which medical devices are regulated in Canada. Health Canada as the federal …

Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, …

Guide to validation – drugs and supporting activities (GUI …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/validation-guidelines-pharmaceutical-dosage-forms-0029.html

They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada. Health Canada inspects …

Software validation documentation for a medical device

https://medicaldeviceacademy.com/software-validation-documentation/

You can develop an algorithm before you write any code, but if you start developing your application to execute an algorithm before you perform a software …

What are the software verification and validation (V&V) …

https://medicaldeviceacademy.com/software-verification-and-validation/

Software Verification and validation is an essential tool for ensuring medical device software is safe. Software is not a piece of metal that can be put into a …

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