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Customer Clinical Evaluation Report (CER) - Validation checklist of clinical Evidence
TÜV SÜD’s Clinical Center of Excellence has compiled a checklist to support medical device manufacturers in making complete and correct submissions of clinical evidence. This is one of the prerequisites for the Notified Body to run the review of the Clinical Evaluation Report (CER) and other relevant clinical documentation quickly and smoothly within the scope of conformity assessment (e.g. design dossier evaluation). The requirements for the CER and other relevant clinical evidence are set forth in the EU Directive and MEDDEV 2.7.1 “Clinical evaluation: a guide for manufacturers and Notified Bodies.”
Available free of charge, the new checklist helps medical device manufacturers to identify gaps in their clinical documentation – such as missing records – early and independently, and complete the documentation well in advance of the Review.
The checklist is available for download as a PDF file here Checklist [ PDF 751 kB ].
Dr. Bassil Akra
Global Director – Clinical Centre of Excellence
TÜV SÜD Product Service GmbH
Dr. Bassil Akra, biomedical engineer with a Master degree in medical engineering and a doctor degree in cardiovascular engineering. Dr. Akra worked for and with medical device companies for many years. He worked on the development of sensors for medical applications, dialysis machines, heart valves, various cardiovascular devices and testing methods. He led a tissue engineering research group and was responsible for the development of new devices, bioreactors and automatic cell isolation machines. During this period he was able to develop and introduce several medical innovation, and won the German innovation Price for medical engineering in 2010. Since 2011, Dr. Akra is working for TÜV SÜD Product Service GmbH. Since 2012, Dr. Akra is the director of the Global Clinical Focus Team at TÜV SÜD Product Service GmbH. Dr. Bassil Akra is a senior product specialist for cardiovascular devices at TÜV SÜD. He is also the senior product specialist for medical devices incorporating medicinal substances and is leading various consultation processes with competent authorities that are designated by the Member States or the EMA. He is presenting as a senior expert worldwide the requirements in Europe and involved in the development of several European guidance documents and standards. He is member of the European Clinical Investigation and Evaluation working group and is representing team NB and NB MED in several European discussions regarding the clinical requirements such as the new European Clinical Specifications for innovative devices.
Dr. Royth von Hahn
Vice President, Medical & Health Services
TÜV SÜD America
Dr. Royth von Hahn is the Vice President, Medical Health Services (MHS) for TÜV SÜD America and the Director for Functional Safety, Software and Innovation of TÜV SÜD’s global MHS Business Unit. He has been involved in several strategic projects within TÜV SÜD including business planning and implementation. Prior to his current role, he was product specialist for ultrasound devices and software and lead auditor for manufacturer certification. Before joining TÜV SÜD in 2007, he was co-founder of a MedTech start-up and an interim professor at a university of applied sciences. Dr. von Hahn holds a Masters degree in physics and industrial engineering as well as a PhD in electrical engineering.