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

Georg Heidenreich - Director Healthcare IT Standards, Siemens Healthcare
  • 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
Siemens Healthcare

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

Steven Abrahamson - Senior Director, Product Cyber Security, GE Healthcare
  • 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
GE Healthcare

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

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

Rostyslav Dorozh - Principal Software Quality Engineer, Medtronic
  • 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

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

Arnaud Sintès - Software Architect & Technical Leader, Zimmer Biomet
  • 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
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

Alexandre Bonnet - R&D Quality Manager, GSK
  • 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

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

Brian Shoemaker - Principle Consultant, ShoeBar Associates
  • 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
ShoeBar Associates

  • 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
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

Paul McCarthy - Co-Founder and Chief Executive Officer, Full Health Medical
  •  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
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

Don Witters (Remote Presentation) - Regulatory Review Scientist, Biomedical Engineer, Center for Devices and Radiological Health, U.S. Food and Drug Administration
  • 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
U.S. Food and Drug Administration

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

Antoun Khawaja - CEO, Khawaja Medical Technology GmbH
  • 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

Khawaja Medical Technology GmbH