Process validation of the injection moulding process and components according to GHTF GHTF/SG3/N99-10:2004 (Edition 2) for a Class IIb product.
Optimized by appropriate statistical methods — employing Pareto principle — in order to achieve optimal confidence with minimal sampling.
Material assessments and supplier contacts for a coating in an aerosol product in Class IIb
Generation of a quality system for a sub-supplier to a medical device company manufacturing implants, undergoing a PMA process at FDA.
The quality system should be according to ISO9001:2015, aligned with ISO13485:2016 and 21 CFR 820, meeting a QSIT audit by FDA.
Biological safety support according to ISO10993-5, ISO10993-10, ISO10993-17, ISO10993-18 and ISO10993-23 for a Combination Product for invasive use.
Coordinator of Nordic group of specialists supporting NAMs instead of animal testing.
Material exchange project for a globally top ten company supplying Combination products.
The assignment involved:
- Scouting of alternative materials, including ceramics, metals, plastics (both engineering plastics and polyolefine) as well as colourants.
- Supplier contacts on a global scale assuring technical and regulatory requirements.
- Coordination of process validation according to GHTF at several large CMOs including multi-cavities (8 to 32) and several (>5) injection moulding tools.
- Generation of protocols according to FDA requirements, and delivering reports accordingly.

CFD simulations of a high-pressure dual-fuel engine (ammonia and diesel) using dynamic mesh modelling and Lagrangian particle tracking

Validation of a soft tissue replicate used for the development of autoinjectors
Performance of benchmark testing on ventricular assist devices using a hybrid mock circulation loop