Regulatory Framework for Medical Devices and IVDs in Europe -- The Notified Body: The Conformity Assessment Body for Medical Devices in Europe -- Quality Management Requirements in Compliance with European Regulations -- Risk Management for Medical Devices in Compliance with EN ISO 14971 -- Medical Device Development -- Safety Requirements for Medical Devices in Compliance with European Standards -- Software as Medical Device in Europe -- Clinical Evaluation and Clinical Investigations of Medical Devices Under the MDR -- Performance Evaluation and Performance Studies of in Vitro Diagnostic Medical Devices Under the IVDR -- Validation of Methods and Analytical Processes for In Vitro Diagnostics -- Medical Products: Packing and Labeling Requirements -- GMP-Compliant Design for Plants Manufacturing Medical Devices -- Integrated Qualification of Manufacturing Systems for Medical Devices -- How to Implement a Risk-Based and Life-Cycle Approach for Commissioning and Qualification -- Management for Critical Medical Device and IVD Suppliers -- Process Validation for Medical Device Manufacturing -- Manufacturing and Quality Assurance in Compliance with the MDR and IVDR -- Mastering Quality System Audits and Inspections for Medical Devices -- Post-Market Surveillance and Vigilance on the European Market -- A Regulatory Guide for Medical Device Start-Ups in Europe: Challenges and Pitfalls.-.