Datum: Tisdag 30 Maj, 2020.
Presentatör: Marie Johansson, senior konsult inom Life Science Innovation på Prevas AB
Presentation Marie Johansson:
The regulatory requirements to place products on the market are becoming increasingly complex. With a good understanding of the intentions, it is easier to maneuver to fulfill the requirements and find robust solutions. The goal is to fulfill the customer's expectations, while the result contributes to an effective and safe final product.
My area of expertise is compliance to the EU regulations (MDD, MDR and IVDR), and the quality system standard (ISO 13485) including design control. In particular I have knowledge of the requirements for the technical product documentation, including clinical evaluation, risk management, software validation, usability and more. Interpretations, gap-analysis, compilation of technical documentation or clinical evidence, and trainings would be some of potential assignments.
My background is as an engineer in Physics, with focus on medical device technology, and I have a medical degree. I have worked 15 years in R&D and Quality at large medical device companies, and 10 years as a Product Assessor for two Notified Bodies (including BSI) for medical devices.