Freelancer Medizintechnik | Biokompatibilität | ISO 10993 | Labor | Analytik

6/2023 – 2/2024

Task
Derive biocompatibility strategy details wrt sampling of different product groups, material characterization and chemical-analytical and biological testing as well as biocompatibility evaluation
Support and coordinate with projects how to apply overarching strategies
Align sampling and testing strategies and support product responsibles how to apply them
Support evaluation of analytical results gained by internal or external testing labs
Coordinate global alignment of laboratory partners (internal and external) as well as analytical methods applied
Provide toxicological evaluations and risk assessments
Support with analytical expert know-how and contribute to the overall biocompatibility reports for the products
Creation of biocomp files in alignment with project progress

Medizintechnik

1/2022 – 2/2023

Langzeit Implantat Klass III - Zulassung in USA begleiten. FDA - Abweichungen bearbeiten/ antworten. Neue Teststrategie, Testlabore suchen/ beantragen - Tests nach 10993-1, -5, -6, -11, -18.

Technische Beratung

11/2019 – 9/2021

Dialyse-Geräte - Biologische Sicherheit und Risikobetrachtung nach ISO 10993-1, -4, -5 und -18. Teststrategie, Testplanung, Durchführung und Testberichte schreiben.

Projektdurchführung