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

"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)

"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"

FDC Consulting - Food Drugs Cosmetics