The topics to be covered in the workshop will range across all aspects of medical device software modeling and synthesis for safety, assurance, security and control, including but not limited to:

• High Confidence Medical Device Software Development & Assurance: Component-based methodologies; design and implementation, verification, validation and testing; robustness and fault-tolerance; system integration and interoperability of heterogeneous systems; closed-loop control; systems of systems; requirements solicitation and capture; clinical data management, and data security
• Modeling & Simulation of operational scenarios: modelling of failures in medical devices; caregivers, and patients behaviour modeling; high fidelity organ/patient models for design & testing; Pharmacokinetic and Pharmacodynamic (PK-PD) models; machine learning models
• Embedded, Real-Time, Networked HCMDSS: Architecture, platform, middleware, resource management, QoS (Quality of Service) in HCMDSS, dynamic interoperation in HCMDSS, including MD PnP (Plug-and-Play) operation, distributed control
• Enabling Technologies for Future Medical Devices: telemedicine, biosensor technologies,  implantable devices, energy harvesting and remote powering devices, medical ultrasound systems, robotic surgery, physiologic signal QoS (Quality of Service)
• Medical practice: User-centric design; use & misuse of MD; risk understanding, and management of failures; medical guidelines and regulations
• Certification of HCMDSS and MD Interoperability:  Regulatory fundamentals, laws, CE marking, FDA approval, pre-clinical testing, clinical evaluation, regulations applicability, incremental certification, role of design tools, approval of non-deterministic and self-adaptive MD systems