Sarah Panten

Sarah Panten has a diverse work experience in the medical device industry. Sarah currently holds multiple roles at Medical Device Knowledge Units (MDKU) e.V., including Co-Founder, Speaker of the Board, and Expert Group Member, starting in March 2022. Prior to that, they co-founded and served as the Managing Partner at avasis, where they focused on product and strategic business development. Sarah also worked as a Senior Consultant in Medical Devices and Business Development at avasis from March 2019 to April 2020.

Sarah has previous experience as a Trainer at TUV SUD from February 2012 onwards. At iThera Medical GmbH, they worked as a Product Manager and lead various quality management and regulatory affairs activities from March 2014 to June 2017. Additionally, they provided Polarion and Development/QM/RA support at iThera Medical GmbH from July 2017 to December 2020.

As an independent consultant, trainer, and medical device expert, Sarah provided consulting, project support, and training to medical device manufacturers. Their work included areas such as product development, risk management, usability, clinical evaluation, implementation of lean QM systems, and implementation of Polarion ALM for digital documentation and workflows. Sarah also implemented risk-based software tool validation processes and conducted clinical evaluations and interfaces risk management for post-market surveillance. Sarah worked as a self-employed consultant from March 2016 to December 2020.

Sarah Panten has also held positions at NSF PROSYSTEM GmbH as a Managing Director and RA/QM Consultant & Project Manager. Sarah was responsible for international contract research organizations specializing in clinical evaluations and clinical trials with medical devices. Sarah provided international consulting services in regulatory affairs, quality, and project management for the medical device industry.

Earlier in their career, Sarah served as an Author/Tutor at oncampus GmbH - E-Learning@FH Lubeck, where they developed e-learning modules on regulatory affairs for medical devices. Sarah also worked as a Project Manager at Siddhi Memorial Hospital Bhaktapur, Nepal, and as an International Product Manager at Olympus Surgical Technologies Europe.

Overall, Sarah Panten's work experience showcases their expertise in various areas of the medical device industry, including business development, quality management, regulatory affairs, clinical evaluation, and project management.

Sarah Panten has a diverse education history spanning from 2002 to the present. In 2002, they attended the University of Applied Sciences Hamburg, where they obtained a degree in Medical Engineering. In 2012, they completed a course for principal investigators of clinical trials at the Koordinierungszentrum für klinische Studien Heidelberg, focusing on project management in clinical trials. Throughout their career, Sarah has pursued various certifications and trainings. In 2015, they attended the TÜV SÜD Akademie to become an Auditor for internal/supplier audits and completed a Training for trainers course. In 2016, they obtained certification as a Certified Professional for Requirements Engineering - Foundation Level from the International Requirements Engineering Board (IREB). That same year, they also updated their knowledge in ISO 13485:2016 at the TÜV SÜD Akademie. Furthering their expertise in the field, they attended the TÜV SÜD Akademie in 2017 to study Medical Device Regulation (MDR) in Detail. Sarah's most recent education background includes completing a Risk Management according to ISO 14971 course at the TÜV SÜD Akademie in 2019. Sarah continues their education there in the same field as they pursue a degree in Risikomanagement nach ISO 14971.