ISO 14155 Certification Services

What is ISO 14155:2020?
ISO 14155:2020 is an international standard that outlines the good clinical practices (GCP) for the design, conduct, recording, and reporting of clinical investigations involving human subjects to assess the safety or performance of medical devices. This standard ensures that clinical trials are conducted ethically and scientifically, with the protection of human subjects as the highest priority. ISO 14155 aligns with global regulatory expectations and enhances the credibility and acceptance of clinical data used for medical device approvals and certifications.

ISO 14155 – Overview
ISO 14155:2020 serves as a comprehensive guideline for managing clinical investigations of medical devices across all phases. It ensures that such investigations generate reliable data while safeguarding the rights, safety, and well-being of participants. The standard applies to manufacturers, sponsors, ethics committees, and clinical investigators involved in medical device trials. It also supports harmonization with other regulatory frameworks such as EU MDR and U.S. FDA requirements, making it vital for global market access. The 2020 revision strengthens ethical considerations, risk management, data integrity, and post-investigation responsibilities.

ISO 14155:2020 Key Requirements
Protect the rights, safety, and well-being of human subjects throughout the clinical investigation.
Ensure scientifically sound design and conduct of clinical investigations for reliable and credible results.
Maintain strict data integrity through accurate documentation, traceability, and record-keeping.
Establish roles and responsibilities for sponsors, investigators, and ethics committees.
Implement quality assurance systems and procedures to monitor trial progress and compliance.
Adopt proper risk management, adverse event reporting, and safety monitoring protocols.
Follow ethical standards aligned with the Declaration of Helsinki and other international guidelines.
Document informed consent processes and maintain subject confidentiality at all times.

ISO 14155 Training and Implementation Support
Quality Asia Certification supports organizations in achieving ISO 14155:2020 certification through structured processes tailored to medical device trials. Our team offers awareness sessions, documentation review, readiness evaluations, and ongoing guidance to ensure conformance to all applicable requirements. We help align your clinical investigation practices with ISO 14155 to strengthen trust with regulators, ethics boards, and stakeholders. Whether your device is in development or undergoing post-market clinical follow-up, adherence to this standard improves the transparency, ethics, and scientific validity of your clinical data.

ISO 14155 Certification Preparation Process
Initial Assessment – Review existing clinical investigation procedures and ethical practices.
Documentation Review – Assist in developing SOPs, trial protocols, and subject information materials.
Compliance Alignment – Ensure alignment with ISO 14155 clauses related to safety, ethics, and data management.
Pre-Audit Evaluation – Conduct internal assessments to identify gaps and prepare for certification.
Certification Support – Provide continuous assistance during documentation submission and audit process by accredited certification bodies.

Contact Us for ISO 14155 Certification
If your organization is conducting or planning clinical trials for medical devices, achieving ISO 14155:2020 certification demonstrates your commitment to safety, ethics, and data integrity. Quality Asia Certification offers complete certification support for ISO 14155, helping you meet international requirements and improve the quality and acceptance of your clinical investigation data. Contact us today to begin your ISO 14155 certification journey.