Ella HelgemanDirector, Regulatory Affairs and Quality Assurance at Nowwell AS
Ella Helgeman is an accomplished Regulatory and Quality Director with over 20 years of experience in the medical device industry and Notified Body. With a Master's degree in Electrical Engineering and an MBA, Ella has gained a deep understanding of the regulatory, clinical, technical and quality requirements for the medical device industry.
Throughout Ella`s career, she has been instrumental in the successful development, launch, and commercialization of numerous medical devices. Ella has also been involved in the development and implementation of quality management systems in compliance with various international regulations.
As a renowned industry expert, Ella has presented at numerous conferences and seminars on regulatory and quality matters. With her expertise in the medical device industry, Ella brings a wealth of knowledge to the table and is highly regarded in the industry.
Ella`s passion for the medical device industry has led to her involvement in numerous industry associations and committees, including RAPS, Team NB, NBCG-Med and Team PRRC. She is dedicated to the advancement of the industry and is committed to ensuring that medical devices are safe and effective for patients worldwide.
Preparing Clinical Data for Review by Notified Bodies, 09:10View Session
Chairperson’s Opening Remarks, 08:30View Session
Chairperson’s Opening Remarks, 13:25View Session