18 - 19 February, 2020 | Berlin, Germany

Main Conference Day Two

9:00 am - 9:40 am Ensure the Security of an Integrated System of Medical Devices

  • Examine the importance of safety and performance in medical devices, legacy devices, and those integrated into IT networks and across multiple platforms
  • Ensure the technical security of your device by considering critical standards and the significance of JWG7
  • Gain an insight into the future of cyber-security and the role of ISO 27001 in risk management
  •  Understand the essential differences between classic safety risk analysis and security threat analysis for connected devices
Georg Heidenreich, Director Healthcare IT Standards at Siemens Healthcare

Georg Heidenreich

Director Healthcare IT Standards
Siemens Healthcare

9:40 am - 10:20 am A Risk Based Approach to Cyber-Security

  • Understand device security within a risk-based design approach
  • Utilise a vulnerability management process to maintain security
  • Explore key strategies to keep the cloud-connected devices secure
  • Analyse the necessity of customer collaboration in safeguarding medical devices
Steven Abrahamson, Senior Director, Product Cyber Security at GE Healthcare

Steven Abrahamson

Senior Director, Product Cyber Security
GE Healthcare

10:20 am - 11:00 am Networking Coffee Break

11:00 am - 11:40 am An Architectural Approach to Medical Device Safety

  • Understand the importance of software functional decomposition in the design of a safe medical device
  • Discover how the use of software architecture safety patterns have major practical uses for cost saving and modular design in software engineering, as well as a guarantee that critical safety properties are met
  • Explore how  software architecture impacts on the effectiveness of risk control measures
Rostyslav Dorozh, Principal Software Quality Engineer at Medtronic

Rostyslav Dorozh

Principal Software Quality Engineer

11:40 am - 12:20 pm Building a medical software platform in a multi-project environment

  • Understand the challenges of building an adaptive software ecosystem with multi-project constraints, in good compliance with medical device standards
  • Heed the numerous tools used by your software teams and their typical workflow
  • Discover best practice for interconnecting your environment systems, using automatisations and a practical software life cycle approach
Arnaud Sintès, Software Architect & Technical Leader at Zimmer Biomet

Arnaud Sintès

Software Architect & Technical Leader
Zimmer Biomet

12:20 pm - 1:20 pm Networking Lunch

1:20 pm - 2:00 pm Development of a Connected Electro-Medical Device: Challenges and Lessons Learned from a New-Comer

  • Ensure the safety and connectivity of your connected electro-medical device by taking guidance from a real-life case study with GSK, exploring the Radio Equipment Directive to the General Data Protection Regulation
  • Overcome the challenges of adapting  your quality management system for connected electro-medical device development
  • Benchmark your compliance practice when factoring in the Medical Device Regulation (MDR) to your development 

Alexandre Bonnet, R&D Quality Manager at GSK

Alexandre Bonnet

R&D Quality Manager

2:00 pm - 2:40 pm Risk Management and the Agile Approach

  • Learn how to implement traditional risk management tools in Agile development
  • Discover the aspects of decision making that mitigate risk
  • Explore how the risk levels of IEC 62304 fit into an Agile world
  •  Look ahead to the planned updates of ISO 14971 and how they will affect your device
Brian Shoemaker, Principle Consultant at ShoeBar Associates

Brian Shoemaker

Principle Consultant
ShoeBar Associates

2:40 pm - 3:20 pm Agile Requires Leadership

  • Discover how peer learning collaboration may be utilised to make every function agile
  • Future Leaders: Learn how agile teams are a training ground for future leaders
  •  Which scaling framework should you use in your company? (Hint it’s a trick question!)
Nancy Van Schooenderwoert, President and Principal Coach at Lean-Agile Partners

Nancy Van Schooenderwoert

President and Principal Coach
Lean-Agile Partners

3:20 pm - 4:00 pm Networking Coffee Break

4:00 pm - 4:40 pm Crossing the line from the Emerging Market of Health Applications to Medical Device

  •  Discover where Health Apps fit into the medical device industry
  • Explore the regulatory differences between Health Apps and medical device software
  •  Looking to the Future: Bridging  the gap from Health application to Medical device software 
Paul McCarthy, Co-Founder and Chief Executive Officer at Full Health Medical

Paul McCarthy

Co-Founder and Chief Executive Officer
Full Health Medical

4:40 pm - 5:20 pm Wireless Medical Devices: An FDA Perspective on Trends, Managing Risks, and the Considerations for the FDA Review Process

  • Explore the trends, challenges, and risks associated with wireless medical devices such as wireless coexistence, quality of service, and security
  • Creating an effective risk management strategy for wireless medical devices from concept through to deployment and maintenance
  • Gain insight into the points to address for submission and scientific review of a wireless medical devices
Don Witters (Remote Presentation), Regulatory Review Scientist, Biomedical Engineer, Center for Devices and Radiological Health at U.S. Food and Drug Administration

Don Witters (Remote Presentation)

Regulatory Review Scientist, Biomedical Engineer, Center for Devices and Radiological Health
U.S. Food and Drug Administration

5:20 pm - 6:00 pm Developing Cardiac Algorithms Yesterday and Today

  • Discuss the complexity in developing a cardiac medical system for analyzing ECG signals in a full-automatic way
  • Highlight the benefits of utilizing Model Based Design as an excellence method for cardiac medical system development
  • Understand the impact of regulatory requirements for high risk cardiac product development
Antoun Khawaja, CEO at Khawaja Medical Technology GmbH

Antoun Khawaja

Khawaja Medical Technology GmbH