In March the ac.biomed team trained two employees of the TÜV SÜD Product Service MHS. The training consisted of theoretical as well as hands-on sessions in the field of heart valve testing. Topics included regulatory background of heart valve testing, the actual testing itself, the respective documentation, product-related risk management and future challenges. During the two day course both sides, ac.biomed and the TÜV SÜD, benefitted from each other’s extensive knowledge and experience in the field of heart valve prostheses.
Nitin Mehta, former regulatory affairs specialist at Edwards Liefesciences, states: “It was a great experience to note that the ac.biomed team consists of pioneers in the cardiovascular field in terms of their technology, services and people.” About the acquired knowledge he explains: “This knowledge helps us to perform the critical function of making sure that the devices sold in the EU are safe and effective as well as serve our client. The training agenda was relevant to our job, meaningful, and hands-on. The experience helped me revise my concepts of fluid mechanics as applicable to heart valves which is critical to performing my job.”
Edoardo Dell’Amico, former R&D product qualification engineer at Sorin Group in Italy, notes: “The training was very well organized and complete in covering all relevant aspects of valve testing.” He further explains: “The collaboration between ac.biomed and the RWTH Aachen University guarantees state-of-the-art methods and technologies and gives continuous input to innovation.” He finally concludes: “In the near future heart valve testing will face new challenges, methods, standardization and adaption to new heart valve replacement/repair technologies. To keep up with these changes it is necessary to keep developing testing methods and technologies, just as ac.biomed is doing. On the other hand, to perform our job as technical reviewers for heart valves and cardiovascular devices it is fundamental to keep up to date with such new technologies and related methods for testing.”
We would like to thank all participants for the successful and productive experience.