Dr. René Bombien has been a board-certified cardiac surgeon since 2011.
Dr. Bombien began his regulatory career in 2011 and worked at TÜV SÜD until 2024 as a Clinical Reviewer and EN ISO 13485 auditor for high-risk medical devices, primarily in the cardiovascular field. From 2021, he served as Chief Medical Officer at the newly established startup TÜV SÜD Denmark MHS, which was designated as a Notified Body for the MDR in April 2024 under identification number CE2443 in the NANDO database. In this role, Dr. Bombien was primarily responsible for MDR compliance of clinical quality management documentation and the clinical team, and secondarily served as Deputy Head of Certification. In 2023/2024, he was part of the MDCG Working Group involved in drafting the MDCG 2024-10 Guidance on Orphan Devices.
He has extensive experience in the assessment of required clinical documentation such as Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Instructions for Use (IFU), Periodic Safety Update Reports (PSURs), Summaries of Safety and Clinical Performance (SSCPs), and clinical investigation documentation in accordance with the Medical Devices Directive (MDD) and the Medical Device Regulation (MDR). His auditing background also gives him deep insight into the necessary quality management documentation related to clinical evaluation, including relevant interfaces with risk management and post-market surveillance (PMS), especially vigilance.
As a trainer at the qtec Academy, he delivers training to medical device manufacturers, pharmaceutical companies, competent authorities, and notified bodies in the fields of clinical evaluation, literature searches, and clinical investigations.
What matters most to him as a speaker: “Traditional lectures are no longer up to date – I focus on actively engaging all participants to build understanding and address their questions. This helps ensure the many MDR requirements can be successfully implemented within their organizations.”
