Astrid is a Human Factors Engineering (HFE) expert with 20 years’ experience in start-up, international mid-sized medtech as well as global pharma companies. She has the understanding of the full development process involving HFE in each stage, from concept generation to validation and tightly linked to risk management.
She contributed to the design of various medical devices such as infusion pump, reusable pen, microneedles, standalone software, class III implant as well as combination products like pre-filled syringe, pre-filled pen and on-body injector. Her experience of users interacting with the products allows her to provide valuable inputs to the product’s user interface (including device, packaging and instructions) as well as to the technical file.
Astrid lead multiple successful Human Factors validations and HF pre-submissions, both in the US and EU, including direct interactions with FDA and EMEA.
She has strong knowledge of regulatory expectations on Human Factors (FDA guidances, ISO 62366, ISO 14971). Astrid is a member of the Human Factors & Ergonomics Society (HFES).
Before specializing in Human Factors Engineering, she acted during 10 years as R&D manager in the medical device field, leading teams of up to 15 persons.
She recharges her batteries in the mountains by hiking, ski touring, paragliding or underwater by scuba diving.
Expertise:
- Human Factors/Usability Engineering
- HF Validation
- Combination Products
- Drug delivery devices
- Risk Management