Medical Devices

In this course you will be able to:

• Understand key definitions of Medical Devices and in vitro diagnostics (IVDs)
• Acquire knowledge about the regulatory framework of the Medical Devices and in vitro diagnostics (IVDs)
• Follow the history of the Medical Devices and the regulatory framework
• Understand the key principles for application of the Medical Devices
• Describe the classifications of the Medical Devices and in vitro diagnostics (IVDs)
• Understand the role of the Notified Body and Conformity assessment
• Acquire knowledge about CE marking and re-certification

In this course you will be able to:

• Understand the Medical Devices development and the lifecycle management under the MDR and IVDR
• Acquire knowledge about the new technologies in the context of Medical Devices and in vitro diagnostics (IVDs)
• Understand the implementation of the digital health and Artificial Intelligence in Medical Devices
• Acquire knowledge about borderline products
• Learn about patient involvement in Medical Devices
• Understand the patient involvement roadmap for Medical Devices development 

In this course you will be able to:

• Understand the general principles about market access and market access for Medical Devices
• Acquire knowledge about procurement for Medical Devices
• Learn about Value-based Healthcare as an approach in Medical Devices
• Understand the different aspects of Value-based innovation

In this course you will be able to:

• Acquire knowledge about the Health Technology Assessment (HTA) principles in Medical Devices and in vitro diagnostics (IVDs)
• Understand key definitions about HTA in Medical Devices
• Acquire knowledge about the EU regulatory framework of HTA and the correlation with Medical Devices
• Learn about the HTA methodologies, including the HTA core model
• Understand about clinical effectiveness and Evidence generation for HTA
• Acquire knowledge about the patient involvement in HTA in the context of Medical Devices