Voluntary Clinical Certification Scheme According to ISO 14155

The compliance to regulatory and state-of-the-art requirements in clinical research is a necessity to protect the well-being and rights of human subjects and to generate high quality and valid clinical data.

The international standard ISO 14155 “Clinical investigation of medical devices for human subjects - Good clinical practice” (GCP) addresses the ethical, scientific and quality principles for state-of-the-art medical device clinical investigations. This standard is already available for many years and compliant studies guarantee a high level of protection for study participants and of data quality.

In this webinar, we will inform you about the TÜV SÜD certification program “Voluntary Clinical Certification Scheme (VoCCS) according to ISO 14155”. This program targets organizations, facilities and sites, that are regularly involved in clinical investigations with medical devices, such as Clinical Research Organizations, Clinical Research Centers, Clinical Investigation Sites and providers of study related services (e.g. for monitoring, data management, data analysis, medical writing, training, auditing and more).

Key Topics Covered:

• Scope of ISO 14155
• Objectives and project basics of the VoCCS audit program

Presented by:

 Dr. Karoline Etschmaier

Clinical Auditor at TÜV SÜD Product Service GmbH

Dr. Karoline Etschmaier holds a PhD degree in molecular medicine from the Medical University Graz, Austria and MSc degrees in biology and clinical research from the Karl Franzens University Graz and the Medical University Vienna, Austria. Her work experience includes academic research in the field of pathophysiology & immunology and clinical research with medical devices, mainly in the areas cardiology and ENT. In clinical research her responsibilities included management of clinical evaluations and investigations, e.g. preparation and maintenance of clinical evaluation reports, study planning and design, regulatory affairs related to clinical aspects, monitoring, data management, reporting and medical writing. As a trained nurse, she is also familiar with health and patient care in different medical disciplines such as traumatology, gynecology, ophthalmology, cardiology and ENT. Dr. Etschmaier is working as Clinical Auditor at TÜV SÜD since 2018.