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"