Quality Management & Psychology | Consulting Keywords: Medical Devices / Pharma Project Management (Europa, USA, Japan), Quality Management, GMP Guidelines and Legislation, e.g., AMWHV, EU-GMP Guideline, ICH Guidelines and FDA/USA 21 CFR 4, 11, 210/211, 820; MEDDEV, MPG, MDD, 93/42/EWG, MDR 2017/745-746; MDSAP); Usability (Usability / Human Factors and Usability Engineering acc. to IEC 62366 / FDA CDRH); DIN EN ISO 13485:2012/2016; Audits / Inspections e.g. FDA; Regulatory Affairs, e.g., Medical Devices (510(k), STED Format), Pharma CMC Part – Module 3, Combination Products / Companion Products, Phyto-Pharmaceuticals, e.g., Registration in Germany Europe, USA, Japan, Korea, Canada, Australia, Brazil); Work- and Organizational Psychology, Communication, Stress-Management, Audit Psychology - audit preparation of personnel, In-House Training & Lecturer for Quality Management...