My main areas of practice
My regulatory expertise covers the placing on the market of medical devices and medicinal products, including clinical evaluation and testing, conformity assessment procedures and authorisation, making available on the market, MDR compliance of economic operators, as well as the representation of companies' interests vis-à-vis authorities and courts.
The area of healthcare compliance includes the legally compliant design of cooperation with healthcare professionals and patient organisations, as well as product-related sales promotion.
I am a leading expert in the area of SHI reimbursement of medical devices in the outpatient and inpatient service area of SHI.
In particular, we advise companies on medical device method assessment procedures (§ 137h SGB V) and testing procedures (§ 137e SGB V).
We have advised numerous (US) companies on the implementation of MDR requirements, including ZOLL Medical Co, Asahi Kasei Medical, Starkey, Galvanize Therapeutics, Pulmonx, Saluda Medical, Procept, Corvia Medical, Route 92, Intersect ENT and ResMed.
I advise my clients in German and English.
Recommendations
JUVE and Legal 500
Publications
I regularly publish in relevant journals and am, among other things, co-author of the medical devices law commentary Lücker/Baumann.
Personal engagement
I am a regular speaker, give trainings in companies and am also involved in local sports clubs (Münchener Ruderclub von 1880).
What others say…
acknowledged expert for life science companies
excellent network
very experienced and good strategist
Articles Written
Mentioned In...
Lawyers I've worked with
-
-
Munich , Germany
- +49 (0)89 620 306 210
- Email Katharina
-
-
-
Munich , Germany
- +49 (0)89 620 306 255
- Email Dr. Franziska
-
