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
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Michael Kremliovsky

Director of Medical Devices and eHealth
Bayer

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Brian Shoemaker

Principle Consultant
ShoeBarr Associates

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Georg Heidenreich

Director of Healthcare IT Standards
Siemens

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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

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John Mulcahy

CEO
HealthGenuity

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
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Amanda Hall

Senior UX Research Lead
Microsoft

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.


Highlights

·        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.

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Visa Suomi

Medical Devices Industry Manager - EMEA
MathWorks

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 
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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
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Brian Shoemaker

Principle Consultant
ShoeBarr Associates