ISO 14155 – Good Clinical Practice for Medical Devices

Are you involved or interested in using medical devices in clinical trials? Be among the first to learn about the significant upcoming changes in the International Standard Organization (ISO) 14155 standard.

The ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice’, coined ‘Medical device GCP’, addresses design, conduct, recording and reporting of clinical investigations carried out in human participants to assess the clinical performance, effectiveness, and safety of medical devices. It is embedded into the Canadian Medical Device Regulations, and training is mandatory for those involved with or using medical device in clinical trials.

A new updated version of ISO 14155(2025) has passed the final stages of the approval process and is expected to be released within the coming weeks to replace the existing ISO 14155(2020).

Don’t miss this opportunity to learn more about this impactful change. Register to attend.

Learning objectives:

After this session, the attendees will be able to:

• Describe the association of ISO 14155 with Canadian regulation
• Identify the main content areas within the document
• Identify the areas and changes that impact site and institution practices
• Understand of the alignment of ISO 14155 with ISO 14971 on risk management

Prerequisite Knowledge:

An understanding of the current ISO 14155: 2020 document is recommended.

Speaker:

Jean Smart, Regulatory Affairs & Quality Officer, Clinical Trials BC
Michael Smith Health Research BC