Mannheim, Baden-Württemberg, Germany
More than 30 years of experience in the world of medical devices, combination products and IVD devices. My knowledges and experiences are the result of my professional career: A strong combination of Quality Management + Regulatory Affaires and R&D, manufacturing, business organisation -- a rather unique combination of skills and real know how. That enables me to cover all imaginable needs of your projects related to my scope in any form, from high levelled consulting down to real hands-on working on processes and documents.
Quality Management / Interim Management for Medical Devices / IVD Devices Quality Management Systems US QSR, 13485, 9001, MDR (MDD), IVDR (IVDD) Product Transfers, Audits, Supplier Management FDA QSRs for Medical devices / IVD Devices ISO 13485 Technical Files / Design History Files for Medical Devices / IVD Devices Risk Management ISO 14971 / MDR Contact to Legal Authorities, Certification- and Notified Bodies
Built up of a QM System ISO 13485, FDA QSR 21 CFR 820, 11, Maintaining the QM System Preparation-, performing- and wrap up of Third Party Audits as QMR Preparation and performing of Internal- and Supplier Audits Product Transfers
Planning, Implementation and Optimisation of production lines for medical devices Technical and organisational support for manufacturing departments Leading position in projects