The International Organization for Standardization (ISO) publishes the ISO standard for good clinical practice (GCP) for the design, conduct, recording and reporting of clinical studies with medical devices. GCP Accordingly the conduct of your medical study is important not only for collecting good quality data in ethical situations, but also for regulatory compliance in the European Union (EU) and the rest of the world.
ISO 14155:2011 specifies the general requirements to protect the rights, safety and well-being of human subjects, to ensure the scientific conduct of clinical investigations and the reliability of results, to determine the responsibilities of sponsors and chief investigators, and to assist sponsors, Investigators, ethics committees, regulatory authorities and other organizations involved in the appraisal of the compatibility of medical devices.
The ISO 14155 standard provides the general specifications and requirements for clinical investigations to:
- Protect the rights, safety, and well-being of human subjects;
- Ensure scientific conduct of the clinical investigation and credibility of the clinical investigation results;
- Define the responsibilities of the sponsor and principal investigator;
- Assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.
Global Manager Group’s team of ISO consultants has designed ISO 14155 documents about requirements for Clinical investigation of medical devices for human subjects – good clinical practice. The key advantage of this ISO 14155 Documents is popular for its user compatibility feature; all the documents covered in 100 MS Word files are editable and written in simple English.
How to get the new ISO 14155 standard?
Conducting clinical investigations in according to the ISO 14155:2020 standard provides a high level of protection for human research subjects and allows companies to conduct international device trials that produce clinical data with high integrity that is accepted by regulatory agencies worldwide. Please take the time to consult our website and let us know if you need help planning and running an ISO 14155 and EU MDR compliant clinical trial.
In any stage of the clinical development, from early feasibility studies and pre-market clinical investigations to post-market studies and registries, medical device manufacturers should comply with the ISO14155 standard to ensure ethical and scientific conduct of the investigation and credibility of the clinical study results.
This new standard has a total of ten annexes (three additional annexes compared to the second edition); three of which are normative annexes and includes requirements. Some of the major changes are:
- A summary of the GLP principles, aligned with ICH-GCP;
- Reference to registration of the clinical investigation in a publicly accessible database
- Guidance on risk-based monitoring and considerations when writing the monitoring plan;
- Guidance on statistical considerations, in line with increasing requirements by Notified Bodies;
- Guidance for Ethics Committees (a new annex);
- Guidance on clinical investigation audits, in line with clinical quality management;
- Reinforcement of risk management according to ISO 14971 throughout the entire process of a clinical investigation;
- Applicability to in-vitro diagnostic medical devices (IVDs);
- Requirements for specific medical expertise in the planning of a clinical investigations.
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