ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice

ISO 14155, Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, provides detailed information regarding clinical investigation principles, the process of planning an conducting a clinical investigation, and the information to be collected. It specifies requirements to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, define responsibilities and assist parties involved in the conformity assessment of medical devices.

good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155 Standard apply to all clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations

ISO 14155 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Niall Services provide ISO 14155 certification services through its team of skilled auditors offering a unique combination of local and international expertise. ISO 14155 certification is applicable to all kinds of manufacturing and service sectors. It applies to all kind of businesses.

Roadmap for ISO 14155
1. Identify the requirements of ISO 14155 to your organisation.
2. Make Decision for ISO Implementation/Certification.
3. Get skilled team or hire services of consultant.
4. Identify GAP Analysis.
5. Make Implementation Plan.
6. PDCA [Plan-Do-Check-Act] cycle.
7. Design, implement, aware about the Quality Policy, Quality Objectives, MS Manual & SOP (Standards Operating Procedure).
8. Establish & evaluate the system and procedure.
9. Identify the boundaries of the management system and produce documented procedures as required.
10. Ensure these procedures are suitable and adhered to.
11. Once developed, internal audits are needed to ensure the system carries on working.

ISO 14155 Certification Assessment
1. Application and Quotation
2. Review Application
3. Agreement with Client
4. Stage – 1 Audit
5. Stage – 2 Audit
6. Certification
7. Surveillance Audit 1 & 2

ISO 14155 Certification Benefit to the Organization
• Emphasis of this standard is to protect human subjects,
• Ensure the reliability of scientific conduct during the clinical investigation,
• Establishes Good Clinical Practices,
• Assist sponsors, monitors, investigators, ethics committees, regulatory authorities, and bodies involved in assessing medical device conformity.

ISO 14155 Auditing and Certification Cost

ISO 14155 Certification charges may depend upon the size, location, Complexity of operation, Processes and it’s inter relevance.
Apply for ISO 14155 Certification
Organizations interested in ISO 14155 certification and searching for ISO certification bodies can contact us.
For a Quotation please get in touch with us either by sending your inquiry through mail to info@isoniall.com or call us at +91 - 99789 71691, WhatsApp +91 - 99786 71691.