researchXchange Biel

Datum:15.06.18
Zeit:12:00 bis 12:45
Ort:Biel
Lokalität: Quellgasse 21 | Raum HG 510 

Medical device manufacturing - a university institute gets ready for clinical studies

Ensuring the health and safety of patients is crucial for medical devices. The design and manufacturing, market access and surveillance are strictly regulated by european directives that now will become more stringent. Suppliers, manufacturers, importers, and distributors are required to establish and maintain a quality management system ensuring that medical devices, regardless of their hazardous potential, comply with harmonized standards or common specifications. To support technology transfer of innovation to medical devices that are ready for market access, the Institute for Human Centered Engineering HuCE of the Bern University of Applied Sciences (BFH) has established a new lab called the HuCE-microCert. As a unique process for a university institute, HuCE-microCert has certified the previously launched quality management system and is now able to produce small batches of medical devices intended for usage in clinical studies. This includes, for example, the assessment of manufacturing processes focused on production and process-monitoring such as sterile packaging and particle control in a clean room environment. Such processes need to be qualified, i.e. validated regularly to guarantee reproducible and stable product quality. The extra efforts for device-specific process validation however, should not significantly reduce the production efficiency. Based on the example of a novel esophageal catheter intended for heart rhythm monitoring, this talk takes on the challenge of quality assurance during medical device manufacturing in a controlled environment.

Speaker

Dr. Thomas Niederhauser is a research fellow at the Institute for Human Centered Engineering at the Bern University of Applied Sciences (BFH). After an industrial apprenticeship in electrical engineering, he received his BSc diploma in electrical and communication technology from the BFH in 2007 and his MSc degree in biomedical engineering from the University of Bern in 2009. From 2007 to 2009, he undertook industrial research at the Institute for Mechatronic Systems at the BFH. He then joined the Cardiovascular Engineering Group of the ARTORG Center of the University of Bern, where he conducted research on low-power hardware and signal processing algorithms for long-term heart rhythm monitoring. In 2014, he earned his PhD in biomedical engineering from the University of Bern. After a short research visit at the Bern University Hospital, he was appointed as lecturer (tenure track) for biomedical engineering at the Institute for Human Centered Engineering at the BFH in 2015. Mr. Niederhauser currently co-heads a certified laboratory focused on medical device manufacturing for clinical studies and recently received a certificate as quality manager in medical technology. He gives undergraduate lectures in feedback control at the BFH and graduate lectures in cardiovascular technology at the University of Bern. His main research and development activities are comprised of novel technologies for long-term recording of physiological functions. In particular, he focuses on the design of low-power hardware and signal processing algorithms for active medical devices intended for cardiac rhythm management and neurological monitoring of preterm infants. 

This Seminar is held in collaboration with the IEEE association.

Registration

Please register for the Seminar. A sandwich and drinks are provided for participants registering until Thursday 12:00h.