Good Clinical Practice ISO 14155:2026 for Medical Devices

Understand the scope of ISO 14155 for good clinical practice in medical device investigations, including interventional trials, pre- and post-market stages, and normative versus informative annexes.

Define safety concepts and the safety event taxonomy for medical devices, including adverse events, adverse device effects, serious adverse events, device deficiencies, malfunctions, and user errors.

Define key clinical terms for medical devices, including clinical performance, clinical evidence, safety, conformity assessment, and clinical investigations, with validation, verification, and independent audits guiding compliant practice.

Align clinical research with ethical principles and regulatory requirements by mastering thirteen GCP principles for medical device trials, from ethics and risk assessment to data integrity and quality assurance.

Explore ethical conduct in clinical studies under ISO 14155, ensuring no improper influence, appropriate compensation, study insurance, public disclosure, independent ethics oversight, and protections for vulnerable subjects.

Protect study participants by ensuring rights to be fully informed, process information, and voluntary decisions, monitor safety, uphold privacy, and address vulnerable populations, under ethics committee oversight.

Outline the ten elements of clinical investigation planning, including risk management, clinical investigation plan, investigator brochure, case report forms, monitoring plan, site selection, agreements, labeling, and data monitoring committees.

Identify risks, assess impact on safety and data, apply controls, and review effectiveness across device, quality system, and clinical study levels under ISO 14,971.

Explain the investigator's brochure (IB) and the clinical investigation plan (CIP) per ISO 14155, detailing regulatory requirements, safety and performance data, and annex B and annex A key elements.

Explain how case report forms capture study data from source documents per CIP, with training and guidelines, and summarize the data monitoring committee's role in safety and progress.

Define a study-specific monitoring plan with risk-based monitoring, critical data points, endpoints, and reporting; then select investigators, assess sites, and establish contracts and labeling.

Discover essential documents for an initial dossier to ethics committees and authorities, including core information, informed consent forms, advertising materials, investigator curricula vitae, case report forms, and approval requirements.

Initiate site initiation after approval, train sites via visit, meeting, or online session, and document site team responsibilities, complex procedures, and deviations from normal practice with signatures before enrollment.

Explore site monitoring activities under ISO 14155, including on-site and remote data verification against source data, adverse event and device deficiency monitoring, and ALCOA data principles.

Ensure close-out and reporting activities are completed. Suspend or terminate a clinical investigation for documented reasons, including risk, data monitoring committee guidance, and ethics committee or regulatory authority actions.

Identify the sponsor's responsibilities for clinical quality management in ISO 14155 medical device trials, covering risk management, planning, conduct, outsourcing, and communication with regulatory authorities.

Explain risk management in clinical investigations via quality by design, balancing residual and subject risks against benefits, with ongoing updates.

Outline the sponsor's planning and conduct responsibilities for clinical investigations, including qualified investigators, training, device accountability, ethics and regulatory approvals, monitoring, risk management, and safety reporting.

Sponsor oversees outsourced duties and functions to safeguard the clinical investigation's quality and integrity, verifies SOP adherence at Ciro's and subcontractors, and ensures roles align with the written agreement.

Notify or obtain regulatory approval or non-objection in the country of the clinical investigation, including amendments. Report progress and safety findings, withdraw investigational device if needed, and assess clinical performance.

Outline the principal investigator’s responsibilities for day-to-day study conduct, data integrity, and subject safety, and describe seven steps for site and investigator qualification and ethics communication.

Provide sponsor copies of ethics committee communications, obtain written and dated approvals before recruiting subjects, and promptly report deviations affecting rights, safety, or scientific integrity, including emergency circumstances.

Explore the informed consent process within good clinical practice for medical devices, detailing the principal investigator's compliance, training requirements for authorized designees, and documentation of the process in source data.

Explain compliance with the clinical investigation plan, including investigator acceptance, source documents, authorized device use, monitoring and audits, protocol modifications with sponsor and authorities, deviations, data integrity, and record retention.

Explain how investigators ensure medical care for subjects during and after clinical investigations, manage adverse events, provide instructions on use and handling of the investigational design, and outline emergency procedures.

Record adverse events and device deficiencies promptly, assess them, and submit reports to the sponsor, ethics committee, and regulatory authorities as required by the clinical investigation plan and national regulations.

The lecture explains sponsor audits under good clinical practice ISO 14155, detailing sponsor organization, training, systems, and quality procedures. It highlights required documents and monitoring for safety and compliance.

Perform an investigator's site audit to verify supervision, task delegation to qualified staff, data integrity between source documents and ecrf, and complete site file documentation.