SO 14155 Certification: Complete Guide to Medical Device Clinical Investigations

What is ISO 14155 Certification?

ISO 14155 is an international standard that specifies Good Clinical Practice (GCP) guidelines for clinical investigations of medical devices that involve human subjects.

It outlines guidelines for planning, conducting, recording and reporting clinical investigations to ensure that the rights, safety and well-being of the participants are safeguarded and reliable, scientifically valid clinical data are generated.

The standard is especially applicable to medical device manufacturers, clinical research organizations (CROs), investigators, sponsors, hospitals, and research institutions engaged in clinical investigations.

ISO 14155 should be considered as the quality and safety standard for medical devices clinical studies. It ensures that clinical investigations are carried out ethically, responsibly and by a proper scientific procedure.

Why is ISO 14155 Important?

The safety, ethics and reliable data of clinical investigations with medical devices are of extreme importance when human participants are involved.

ISO 14155 assists organisations to:

·         Ensure that the rights, safety and welfare of participants are safeguarded.

·         Provide accurate and reliable clinical information, applicable to scientific research.

·         Develop standard clinical investigation practices.

·         Enhance documentation & traceability.

·         Support regulatory submissions.

·         Reduce risks associated with clinical investigations.

·         Boost patient, investigator and regulator confidence.

Good clinical practice principles increase the likelihood that medical devices will be assessed before and after they become available.

How Does ISO 14155 Work?

ISO 14155 lays out the requirements and guidance for the entire clinical investigation lifecycle.

The standard is based on:

·         Planning and design of clinical investigations.

·         Risk assessment and risk management.

·         Investigator and site selection.

·         Informed consent.

·         Ethical considerations.

·         Protection of clinical investigation participants.

·         Collection and documentation of data.

·         Monitoring and quality control.

·         Reporting of adverse events.

·         Clinical investigation documentation.

·         Final reports and record keeping.

The standard highlights the key points of accuracy, reliability, traceability and scientific credibility of clinical data.

What is an Organization Required to Do?

Organizations that are running clinical investigations must:

·         Design a well-defined clinical investigation plan.

·         Recognize and deal with potential hazards.

·         Identify the investigator(s) and clinical sites.

·         Obtain appropriate ethical approvals.

·         Get informed consent of participants.

·         Train investigators; study personnel.

·         Maintain accurate clinical records.

·         Continue to follow up the investigation.

·         Report any safety concerns and adverse events in an appropriate manner.

·         Ensure confidentiality of participant information.

Documentation is of great importance as clinical investigation records are evidence that the clinical investigation has been carried out in accordance with the approved clinical investigation plan and the requirements.

Certification / Implementation Process – pretty Systematic

Typical ISO 14155 implementation steps:

·         Understanding ISO 14155 requirements.

·         Creating the clinical investigation plan.

·         Carrying out risk assessment and management.

·         Identification of competent investigators and study locations.

·         Getting ethical and regulatory approvals.

·         Instruction of clinical investigations staff.

·         Investigating and monitoring.

·         Gathering, summarizing and analyzing clinical information.

·         Preparing the clinical investigation report.

·         Keeping records and taking corrective action as needed.

Regulatory and approval specifications may differ from country to country and medical device regulations.

Recent Trends & Industry Insights

Clinical investigations for medical devices are becoming more and more technology intensive.

Current trends include:

·         Distributed and decentralized clinical trials.

·         Electronic data capturing systems.

·         Digital patient monitoring.

·         Wearable medical technologies.

·         Real-world clinical data.

·         Artificial Intelligence in clinical research.

·         Risk-based monitoring.

·         Informed consent systems using electronic means.

These technologies can enhance the efficiency of data collection, engagement of participants, monitoring, and clinical investigation overall.

Advantage of ISO 14155 Compliance

There are several benefits to consider:

·         Better protection of clinical investigation participants.

·         Better quality and reliability of clinical data.

·         Improved clinical investigation processes.

·         Improvements to documentation and traceability.

·         Improved regulatory readiness.

·         Patients' and investigators' gains in confidence.

·         Assistance with medical device development and approval.

·         Improved overall clinical research quality.

Adhering to ISO 14155 is a sign of a commitment to ethical, scientifically valid and participant-oriented clinical studies.

Conclusion

The ISO 14155 standard is an international standard for clinical investigation of medical devices based on Good Clinical Practice principles. It facilitates the safety of participants, clinical risk management, data integrity and systematic and ethical investigations.

Medical device manufacturers and clinical research organizations leveraging ISO 14155 will be better able to enhance the quality of clinical studies, increase regulatory confidence, and help develop safer and more effective medical devices.