3 FEB: Main Conference Day One - All Times CET

11:50 am - 12:35 pm Opening Remarks and Presentation 1: Cyber Security for Medical Devices and Lessons Learned from the Covid Pandemic

Rüdiger Rissmann - Technical Lead Cyber Security Improvement Program, Roche Diagnostics
Brian Shoemaker - Principle Consultant, ShoeBarr Associates

- Everybody is talking about Covid tests these days ... anyone thinking about medical devices?

- Work from home, social distancing ... how does this affect medical devices?

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Rüdiger Rissmann

Technical Lead Cyber Security Improvement Program
Roche Diagnostics

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Brian Shoemaker

Principle Consultant
ShoeBarr Associates

12:35 pm - 1:10 pm How to Prevent Hackers from Compromising Your Medical Devices

Andrew Hoyt - Principal Software Engineer - Connected Health, Irdeto
  • A recent survey by Irdeto found that 82% of healthcare organizations have experienced an IoT-focused cyberattack in the past year, with 30% of attacks resulting in compromised end-user safety. This alarming finding indicates that global care providers must continue to evolve their security approach to ensure the security of care facilities, medical devices and the safety of patients.
  • In this demo session, we’ll explore some of the techniques attackers are using to break into connected medical devices to steal valuable patient data and intellectual property.

·        We’ll also explore some of the tools developers and manufacturers can make use of to fight back against these attackers.

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Andrew Hoyt

Principal Software Engineer - Connected Health
Irdeto

1:10 pm - 1:45 pm The Bridge From Front End Innovation To Highly Regulated Processes

Robert Lurf - Product Engineering Manager, QUO AG


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Robert Lurf

Product Engineering Manager
QUO AG

1:45 pm - 2:00 pm Content Coffee Break

2:00 pm - 2:35 pm Utilising Process Mining for Device Development and Process Insight

Jan Van Moll - Director of Quality and Regulatory, Philips

·        Discuss the current application of process mining in medical device data management

·        Analyse how you can utilise and then mine your device process data for insights into process execution

·        Examine how you can utilise process mining to generate insight into your device quality systems with a case study of Philips’ experience

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Jan Van Moll

Director of Quality and Regulatory
Philips

2:35 pm - 2:55 pm A UK Viewpoint in Relation to Recent Updates on Implementation of MDR

Guido Fumagalli - Senior Specialist, Devices Software & Apps, MHRA (Devices)
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Guido Fumagalli

Senior Specialist, Devices Software & Apps
MHRA (Devices)

2:55 pm - 3:45 pm Content Coffee Break

3:45 pm - 4:20 pm Health Governance: From People to Process and Back Again

Hannah Murfet - Senior Compliance Manager, Microsoft

·        Discuss key considerations and critical success factors for data health governance

·        Consider the role and requirements for the people behind the data and the people using the data

·        Analyse the implications and considerations for the end users of these technologies

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Hannah Murfet

Senior Compliance Manager
Microsoft

4:20 pm - 4:55 pm AI ‘Beyond The Buzzword’ In Software Development: Understanding The Regulatory And Standards Landscape For AI Adoption

Pat Baird - Head of Global Software Standards, Philips
  • Discuss the current adoption of AI technologies in Software for Medical Devices and Software as a Medical Device to identify opportunities for further progression
  • Analyse the current global standards and regulations for AI within medical software to identify critical process and development considerations
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Pat Baird

Head of Global Software Standards
Philips

  • How digital eco system improved Clinical Development and Patient participation
  • How Covid influence this digital business transformation
  • New technology like Medical Device and AI bring compliance challenges
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Mathieu Materne

IT Compliance Lead, Global Technology Officer, NewMeds and Medical Devices
UCB

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Laurence Mertens

IT Validation lead in Pharmacovigilance, Clinical and Regulatory Area
UCB

5:30 pm - 6:15 pm Taking a Medical Industry Perspective: Building a data driven future to optimise your device and software risk management processes and CLOSING REMARKS DAY 1

Diarmuid Cahalane - Co-Founder and Director of Regulatory Affairs, Metabolomic Diagnostics
Brian Shoemaker - Principle Consultant, ShoeBarr Associates
  • Discuss the changes and opportunities in regulatory approval pathways for devices and software as a medical device in light of Covid-19
  • Examine the importance of collaborating with broader stakeholders - including clinicians – to optimise your device development 
  • Analyse the ongoing shift to remote healthcare and software as a medical device in light of Covid-19 – what are the challenges to maintaining data integrity with remote health monitoring
  • Identify critical success factors in ensuring regulatory alignment for your device development
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Diarmuid Cahalane

Co-Founder and Director of Regulatory Affairs
Metabolomic Diagnostics

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Brian Shoemaker

Principle Consultant
ShoeBarr Associates