4 FEB: Main Conference Day Two - All Times CET

12:00 pm - 12:45 pm Summary of Day 1 and Presentation 1: Validation, Regulatory, and Ethical Considerations For Intelligent Cyber-Physical Systems

Michael Kremliovsky - Director of Medical Devices and eHealth, Bayer
Brian Shoemaker - Principle Consultant, ShoeBarr Associates
  • Consider the adoption and evolution of Cyber-Physical Systems across the medical device landscape
  • Examine the regulatory implications and considerations for approval of these systems - and the corresponding Intelligent Agents
  • Identify the role and value of stakeholder collaboration – both internal and external - in furthering development of these systems with a focus on the role of governmental collaborations

Michael Kremliovsky

Director of Medical Devices and eHealth


Brian Shoemaker

Principle Consultant
ShoeBarr Associates


Georg Heidenreich

Director of Healthcare IT Standards


Martin Meyer

Director Technical Regulations and Standards
Siemens Healthcare

1:20 pm - 1:55 pm Connected Devices And Remote Health Management – Exploring The New Norm

John Mulcahy - CEO, HealthGenuity

·        Explore a new healthcare norm: enabling personalised and remote patient care through connected medical devices and software as a medical device

·        Examine implications on software design and development under Covid-19 as we increase the connectivity of our medical and health management

·        Identify key quality management and compliance considerations for achieving sustained industry growth in connected devices


John Mulcahy


1:55 pm - 2:20 pm Content Coffee Break

2:20 pm - 2:45 pm Re-imaging Healthcare During COVID-19 with User Experience Research and Design

Amanda Hall - Senior UX Research Lead, Microsoft

  • Discuss how design thinking and an iterative design approach are being applied to COVID-19 response efforts with Artificial Intelligence (AI)
  • Examine the patient COVID-19 journey and how to implement user research methodologies that lead to the design and development of medical devices and applications that engage and delight users
  • Assess how the pandemic is changing the healthcare experience and how UX research has changed to address these new use cases to create technology that meets stakeholders’ needs in a more globally connected world

Amanda Hall

Senior UX Research Lead

2:45 pm - 3:30 pm Improving quality in medical device development with Model-Based Design

Visa Suomi - Medical Devices Industry Manager - EMEA, MathWorks

Whether you are an embedded software developer or an engineer designing a medical device, software quality is critical for patient safety.

Model-Based Design incorporates verification and validation into the software development workflow. As a result, the software is comprehensively tested and verified before you integrate it into a medical device. In addition, most of the documentation required by IEC 62304 are automatically generated for regulatory compliance. 

But how does Model-Based Design work in practice? And how do you get started? Join this webinar to learn the best practices for improving software quality while reducing development time and costs.


·        Requirements management and system architecture design

·        Automated unit and system level testing with test report generation

·        IEC 62304 supported workflow for FDA/MDR regulatory compliance

Who Should Attend

Embedded software developers, system engineers and managers in charge of V&V processes and regulatory compliance for medical device design.


Visa Suomi

Medical Devices Industry Manager - EMEA

3:30 pm - 3:45 pm Content Coffee Break

3:45 pm - 4:20 pm Implementing The MDR Across Your Medical Device Software: Key Considerations And Challenges

Erich Zanner - Senior Quality Site Leader, GE Healthcare
  • Discuss the guidelines and implications of May 2021s MDR deadline for medical device development
  • Hear how GE Healthcare have embedded MDR compliance across their medical software products
  • Develop a roadmap to MDR compliance by identifying solutions to commonly identified challenges and pitfalls 

Erich Zanner

Senior Quality Site Leader
GE Healthcare

4:20 pm - 5:05 pm Software As A Medical Device: Balancing The QA And Development Perspectives AND CLOSING REMARKS FOR 2021 SDMD CONFERENCE

Brian Shoemaker - Principle Consultant, ShoeBarr Associates
  • Discuss the impact of Covid as a catalyst in pushing development of products such as diagnostics and combination devices to push medical attention and healthcare out of the clinical environment
  • Identify the QA and Compliance challenges to remotely accessing these devices and hosting them on the cloud – patient data implications as well as security implications
  • Assess the increasing focus on cyber security for remote devices and software to identify opportunities for embedded risk mitigation

Brian Shoemaker

Principle Consultant
ShoeBarr Associates