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.