Medical Devices and In Vitro Diagnostics

<p>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.- </p><div><p></p></div>