Clinical Investigation of Medical Devices – ISO 14155:2020

When a medical device fails, the root cause is often weak clinical evidence, not the technology itself. The PIP implant and DePuy ASR hip scandals proved it, and they reshaped how regulators demand that evidence worldwide. ISO 14155:2020 is the international standard governing how clinical investigations of medical devices on human subjects are planned, conducted and reported, and it underpins compliance with EU MDR 2017/745 and FDA 21 CFR Part 812. This two-hour online training turns every clause into one clear method to apply from first subject to post-market follow-up.

Across ten lessons, this certified course covers every section of the standard with real case studies, from ethics and planning to safety reporting and inspection readiness. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply ISO 14155 in practice.

What you’ll learn

• Position ISO 14155:2020 against EU MDR, FDA 21 CFR Part 812, ISO 14971 and ISO 13485
• Apply the 13 principles of ISO-GCP to plan a compliant investigation, from the CIP and Investigator’s Brochure to the statistics
• Run a Clinical Quality Management System and risk-based monitoring at study, site and process level
• Classify and report adverse events, device effects and deficiencies within required timelines
• Keep GCP compliance when using digital tools, including electronic informed consent and decentralised studies
• Pass an EU MDR or FDA inspection, using real FDA findings to anticipate the deviations auditors flag

Who should enroll

• Clinical research associates, monitors and project managers in medical devices
• Sponsors, principal investigators, study coordinators and research nurses
• Quality assurance, regulatory affairs and clinical operations teams
• Notified Body, CRO and post-market surveillance professionals

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum

Lesson: A Brief History of Clinical Investigation of Medical Devices

Lesson 1: Scope, Structure and Regulatory Landscape of ISO 14155:2020

Lesson 2: Ethical Considerations and Informed Consent

Lesson 3: Clinical Investigation Planning

Lesson 4: Responsibilities of the Sponsor and the Clinical Quality Management System

Lesson 5: Responsibilities of the Principal Investigator

Lesson 6: Conducting the Clinical Investigation

Lesson 7: Adverse Events, Device Deficiencies and Safety Reporting

Lesson 8: Suspension, Termination and Close-out

Lesson 9: Post-Market Clinical Follow-up

Lesson 10: Essential Documents, Audits and Inspection Readiness

Conclusion

Glossary

Final Assessment