The International Organization for Standardization (ISO) has released the updated ISO 14155:2026 standard, Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice. This revision builds upon ISO 14155:2020 and reflects the evolving landscape of medical device clinical investigations, including advancements in technology, risk management practices, data integrity expectations, and patient protection considerations. The updated standard further aligns clinical investigation requirements with contemporary regulatory expectations and global best practices.

The revision introduces clarifications, refinements, and new requirements across key areas of clinical investigation planning, conduct, oversight, documentation, monitoring, safety reporting, and data management. Particular emphasis has been placed on risk-based approaches, proportionality, investigator and sponsor responsibilities, informed consent processes, and the integration of digital technologies and decentralized elements where appropriate.

The updates to ISO 14155 are extensive and may have significant implications for medical device manufacturers, sponsors, investigators, contract research organizations (CROs), ethics committees, and regulatory professionals. Understanding the differences between ISO 14155:2020 and ISO 14155:2026 is critical for ensuring compliance, maintaining inspection readiness, and effectively implementing the revised requirements across clinical investigation programs. This comparison tool provides a side-by-side analysis of the changes, helping stakeholders identify new expectations, assess potential impacts, and develop implementation strategies for the updated standard.

Includes:

• Unlimited access to one Excel format comparison tool

Audience

All clinical research personnel

ONBOARDING OR ANNUAL REVIEW CURRICULUM

This course can be used alone or as part of the full curriculum, including:

1. GCP Training: ICH E6(R3) - Available HERE

2. Good Documentation Practices and ALCOA-C - Available HERE

3. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE

4. Structure and Content of Clinical Study Reports (ICH E3) - Available HERE

5. Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) - Available HERE

6. Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE

7. Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - HERE