Voluntary Clinical Certification Scheme 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 ISO 14155 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. The principles set forth in the standard are intended to be followed for pre-market and for post-market clinical investigations, as far as relevant.  The clinical development stages outlined include pilot, pivotal and post-market stages, covering interventional 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 is 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 Voluntary Clinical Certification Scheme (VoCCS)?

The Voluntary Clinical Certification Scheme (VoCCS) 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). The VoCCS 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 VoCCS 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. Certification validity is managed within TÜV SÜD Mark program that ensures an initial certification and an annual surveillance.

VoCCS 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?

TÜV SUD Mark not only provides well-known certification and corresponding trusted name but also offers working with expert auditors who are highly experienced in in the clinical research and medical device fields considering up-to date information.