REFERENCES
- Preparation for certification according to DIN ISO 9001:2008, DIN EN ISO 13485 and
DIN ISO 14001
- Creation of design dossiers and clinical evaluations for Class III medical devices
- Technical documentation for medical devices
- Creation of product information files and safety reports for cosmetic products
- Development of the medical rationale behind food for special medical purposes
- Reports drawing the line between medicinal products/medical devices, cosmetic products/medicinal products, and biocides
PUBLICATIONS
- "L-arginine with folic acid in arteriosclerosis, hyperhomocysteinaemia and vascular disorders of diabetics: a new form of optimised, dietary treatment", Lebensmittel & Recht supplement 3/2004 (in German)
- "The amending Medicinal Products Directive 2004/27/EC: New impetus in drawing the line between 'dual-use' products and medicinal products?" Part I: Pharmaceuticals Law, 11/2004;
Part II: Pharmaceuticals Law 12/2004 (in German)
- "Drawing the line between medicinal products and food for special medical purposes", Lebensmittel & Recht, 3/2005 (in German)
- "Herbal ingredients with positive health benefits in food supplements – Practical aspects in the competition-law dispute", Pharmaceuticals Law, 10/2005 (in German)
TALKS
- "Contracts for demarcating liability for medical devices", Beuth-Seminarreiche Medizinprodukte, 2004/2006
- "The latest on food for special medical purposes", a talk as part of BAH's "Limits of medicinal products" working group meeting in Bonn, Germany
- In-house training "Requirements compared: IFS HPC, DIN EN ISO 22716 and DIN EN ISO 13485"