MedTech GCP Service Program acc. to ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects

ISO 14155 Standard

ISO 14155:2020 (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 for how to implement Good Clinical Practice (GCP) for pre- and post-market clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

Highlights of the Standard

The ISO 14155 standard provides 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, and
• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

The ISO 14155 standard defines 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.

Related Medical Device Standards

With an ever-changing regulatory environment worldwide and a constantly increasing public awareness for study outcomes the bar for clinical investigation quality and transparency continually rises, demanding high organisational, scientific, medical, ethical and technical competences of all involved parties.

ISO 14155 specifies interrelations of the clinical quality management with other medical device standards and best practice guidance, including e.g.:

• ISO 14971 – Application of Risk Management to Medical Devices
• Declaration of Helsinki

What is the medtech GCP service program (formerly known as VoCCS)?

The MedTech GCP Service Program is designed to evaluate compliance with Good Clinical Practice (GCP) principles according to ISO 14155, enabling the audited service provider to deliver state of the art service(s). MedTech GCP focuses on the clinical quality management (CQM), with the related responsibilities, processes, procedures and templates for design, conduct, record, and reporting of clinical investigations.

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.  

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.

Why Certification with a TÜV SÜD Mark Program?

In partnering with TÜV SÜD you will benefit from our long-standing experience in product-, and service-certifications and our dedicated team with expert knowledge and experience in the fields of clinical research and medical devices.