JoinHealth - Spring welcome series 2024

Understanding Medical Devices Regulation

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Opening 

• Patrícia Patrício
  Health Cluster Portugal

• Marta Passadouro
  EIT Health Innostars

Essential steps for CE mark

• Sandra Balseiro
  Instituto Pedro Nunes

Q&A

Technical and usability requirements according to the MDR: Case study

• João Quintas
  Instituto Pedro Nunes

Q&A

CE Marking Success Story: Difficulties in the transition from Directive 92/43/CE to European Regulation 2017/745

• Célia Ludovino
  BHL-Medical

CE Marking Success Story: Mastering European Regulation 2017/745 for the first time

• Ana Abreu
  Kinetikos Health

Q&A and general discussion with the speakers

Closing

How to get your Digital Therapeutics (DTx) reimbursed in Europe

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Opening 

• Patrícia Patrício
  Health Cluster Portugal

Early Access to Reimbursement for Digital Medical Devices (PECAN) in France

• Vincent Vercamer
  Project Director – Market Access expert, Digital Health Delegation, French Ministry of Health

Q&A

The Belgian mHealth reimbursement framework: an exercise in digital care pathways

• Wim Dunford
  Attaché telemedicine, RIZIV-INAMI Belgium

Q&A

Hope Care's Experience with the Reimbursement Systems in France and Germany

• José Paulo Carvalho
  CEO HopeCare

Q&A and general discussion

Closing

AI Act and the impact in Medical Devices Regulation

Opening 

• Patrícia Patrício, Health Cluster Portugal

• Marta Passadouro, EIT Health Innostars

Software as a Medical Device: Good Practices 

• Eduardo Barbosa, Fraunhofer Portugal

Topics:

• The importance of establishing requirements: identifying stakeholders, elicitation techniques, establishing traceability

• Good practices for coding: coding styles and documentation, use of version control and code branching strategies

• Testing strategies and methodologies: mastering the art of test cases, tools for automating tests

• Cybersecurity and interoperability: general concerns

AI Software: Good Practices

Inês Lopes, Fraunhofer Portugal

Topics:

• The importance of best practices in the AI regulatory landscape.

• Guidance measures AI system stakeholders can undertake at governance, process, and product levels.

• Tools supporting the development of responsible AI systems.

Q&A

European Regulation for Software as a Medical Device

Sandra Balseiro, IPN

Topics:

• Define SaMD and an overview of the specific regulations governing SaMD

• Explain the classification criteria for SaMD and examples of SaMD classifications and their regulatory implications

• Challenges and considerations associated with regulating SaMD (Data security and privacy concerns; software updates)

European Regulation and AI ACT

Ana Brito, IPN

Topics:

• AI ACT and its implications for medical devices, including SaMD.

• Similarities/Complementarities between AI ACT with MDR/IVDR requirements:

• Requirements for bringing MDs/IVDs with AI systems to the European market

• Conformity assessment and obtaining CE Marking for MDs/IVDs with AI components 

Q&A

Real world Example: Peeking Window 

Cristiana Braga, Filipe Soares, Fraunhofer Portugal

Real world Example: Digestaid

Miguel Mascarenhas

Q&A and general discussion with the speakers

Closing

Mastering Clinical evaluation for Medical Devices

Opening 

• Patrícia Patrício, Health Cluster Portugal
• Marta Passadouro, EIT Health Innostars

Understanding regulatory requirements for clinical evaluation

Sandra Balseiro/Celeste Oliveira, Instituto Pedro Nunes

Topics:

• Definition and importance of clinical evaluation in medical device development
• Clinical evaluation considerations integrated into the design and development process
• Regulatory requirements and guidelines for clinical evaluation
• Strategies for achieving regulatory compliance throughout the clinical evaluation process.

Clinical Investigation with Medical Devices: Life-cycle phases

Lúcia Domingues/Catarina Silvério, NOVA CRU

Topics:

• Overview of the clinical investigation life-cycle phases 
• Key factors of each phase
• Safety assessment and management throughout the clinical investigation

Q & A

Real-world Experience of Insparya

João Leite, Insparya

Real-world Experience of C-mo Medical Solutions

Sara Lobo, C-mo Medical Solutions

Q & A and general discussion with the speakers

Closing