As an expert for Quality Management and Regulatory Affairs for Medical Devices, I am offering consultancy services for a wide range of international regulatory requirements as written down in standards and regulations (like ISO13485, ISO14971, 21CFR820, 93/42/EEC, MDR 2017/745). Current and past projects in several international companies include - Process Validation IQ, OQ, PQ - PRRC (article 15 MDR) - Notified Body Audit & FDA Inspection Readiness - Interim Quality Management (MDD Class I-III) - Design Control for drug device combination products - Internal and Supplier Auditing - Production Transfers, Process and Cleanroom Validations Based on a long-year experience in both development and operations, Working both onsite and remote, I am providing safe, simple and sustainable solutions tailored to your Needs.