MedTech GCP Service Program (ISO 14155 Standard)

ISO 14155 (Clinical investigation of medical devices for human subjects – Good Clinical Practice) is the latest edition of the standard for the design, conduct, recording and reporting of medical device clinical investigations. The standard provides guidance to clinical research professionals on how to implement Good Clinical Practice (GCP) for pre- and post-market clinical investigations carried out in human subjects to assess the safety, quality and performance of medical devices.

ISO 14155 guidelines provide the requirements for clinical investigations 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 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. 

ISO 14155 guidelines define the requirements on clinical quality management, the state-of-the-art approach to gather, record, and analyse relevant data on the quality, performance, and safety of a medical device throughout its entire life cycle covering pre-, and post-market phases and clinical investigations such as first in human, feasibility and pivotal clinical investigations, but also observational and non-interventional clinical investigations.

The MedTech GCP Service Program is designed to evaluate compliance with GCP principles according to ISO 14155 regulations, enabling the audited service provider to deliver state-of-the-art services. TÜV SÜD’s MedTech GCP service focuses on clinical quality management (CQM) with the related responsibilities, processes, procedures and templates for design, conduct, recording, and reporting of clinical investigations. MedTech GCP certification can help to increase regulators, business partners, medical device users, and patients’ confidence and trust in the service provided by a service supplier. 

TÜV SÜD offers MedTech GCP certification for service providers who are regularly involved in clinical investigations with medical devices such as Clinical Research Organisations (CROs), Clinical Research Centers and Clinical Investigation Sites.

Our internal certification program is an audit program for the assessment of compliance of an organisation´s clinical quality management (design, conduct, record and reporting of clinical studies) with the GCP standard ISO 14155 regulations and/ or ISO 20916. This international ISO 14155 certification program leads to:  

• International recognition of clinical study results 
• Facilitation of the selection process of clinical research organisations / centres / sites 
• Common quality standard for the wellbeing and protection of human subjects in clinical studies