Register today to attend Software as a Medical Device Digital Week, our free-to-attend webinar series featuring critical updates to Software Regulations for Medical Devices from the European Commission and Notified Bodies as well as updates from industry on key SaMD topics. To learn about sponsorship of future events, contact

DAY 1 – April 26, 2021

The Legislative Proposal for a European Approach on AI by the European Commission
9am EST / 2pm BST / 3pm CET

  • Background and rationale of the EU regulatory framework on AI
  • Main elements of the regulatory framework on AI
  • Interlink with existing EU legislation on medical devices
  • Understanding what questions you should be asking
  • Learning how your companies should be supporting you


Gabriele Mazzini
Legal and Policy Officer
European Commission

Salvatore Scalzo
Policy and Legal Officer, AI
European Commission

View More Details +

Medical Device Software, Regulatory requirements and the MDR
10am EST / 3pm BST / 4pm CET

  • Introduction, What is medical device software?
  • MDCG Guidance on Software
  • Software qualification and classification
  • General Safety and Performance Requirements
  • State of the Art and AI


Dr Fiona Dunn
Senior Technical Specialist & Scheme Manager, Active Devices, Medical Devices

Dr Aris Tzavaras
Technical Specialist & Scheme Manager, Active Devices, Medical Devices

View More Details +

DAY 2 – April 27, 2021

How to Make a Profit with Data while Complying with the GDPR?
9am EST / 2pm BST / 3pm CET

  • General Data Protection Regulation review related to software and AI
  • Creating value with data, AI and the re-identification of anonymized datasets
  • Where does the line cross for things like heart rate monitoring (ie. data re-use to improve services, data disclosures to third parties etc.)?
  • What are the rules around CE marking for these companies?


Jan Dhont
Partner, Privacy and Cybersecurity
Wilson, Sonsini, Goodrich & Rosati

Nikolaos Theodorakis
Of Counsel
Goodrich & Rosati

Laura Brodahl
Goodrich & Rosati

View More Details +

The Persuasive Power of Data Visualization Across the Clinical Trial Management Spectrum
10am EST / 3pm BST / 4pm CET

Data plays the fundamental role in a clinical trial. As medical technologies continue to advance, the sources of data collection are expanding past just one clinical trial database. Methods including but not limited to wearables, mobile applications, eDiaries, real-world evidence, outcome assessments, imaging, EHRs and EMRs are all sources for data collection and can be housed in different places. It’s critical for companies to successfully manage and identify meaningful, actionable insights that impact a trial. By using an intuitive data visualization tool, large amounts of sensitive trial data from various sources can be translated into meaningful information in just one application. Join us to learn more about how data visualization increases efficiency in the incredibly complicated clinical trial process.

  • Why: Benefits and Advantages of Data Visualization Technologies in Clinical Trials
  • What: Power BI Dashboard and Reporting Tool
  • How: Using Data Pooling and Automation to Visualize Real-Time Clinical Study Data
  • Case Studies: Successful Uses of Power BI Visualization in Clinical Trials Today


Mark McIlduff, MS, MBA
General Manager, U.S. Operations

Hailey Jannetty, MS
Sr. Data Analyst

View More Details +

REGISTER NOW – Please select the webcast(s) you wish to attend and enter your contact details

Day 1

Day 2