MedTech SPIN: Understanding Software Bill of Materials

MedTech SPIN: Understanding Software Bill of Materials
The MedTech SPIN Sub group - Software as a Medical Device - is delighted to welcome you to this presentation.  Georg Heidenreich  will give us an insight into understanding Software Bill of Materials.





Date: Tuesday 25 October 2022
Time: 11:00-12:00 BST (GMT +1)/12:00-13:00 CEST


Introduction: Dr Celia Cruz, Head of Regulatory Affairs, Complear, Portugal

Guest Speaker: Dr Georg Heidenreich, Senior Key Expert: Software - IT and Data Security, Siemens Healthineers. In 1996, Dr Heidenreich finished his doctoral engineering thesis at the Engineering Faculty at Erlangen-Nuremberg University – concluding a research grant project. 

Whether it is a software as a medical device or a software in a medical device, digital solutions are increasing their impact in the real world, as they are being more widely applied. In the last few years, regulating entities and legislators across the globe are looking into how to approach their safety and security. One of such approach is through a software bill of materials (SBOM), that can be positioned as a valuable instrument for IT risk management. SBOM has been highlighted by an FDA pre-market guidance and by an IMDRF paper on medical device cybersecurity recently.

In this session we will look into what is the SBOM and its importance, and how to approach over the device life cycle and for the different stakeholders.
 

There will be a Q&A session at the end.


Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

 

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When
25/10/2022 11:00 - 12:00
Where
ONLINE
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