11
Nov
2009

EU Borderline and Classifcation Committee SW group

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0

The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been circulated as a starting point. See the report at the link provided. This, as well as other EU activities related to changes in wording in the device directives related to software and Health Canada’s recent reclassification of patient information systems, indicates increased focus on healthcare information systems and standalone software.

Medical Information Systems Report 2009

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Being Agile & Yet Compliant (Public)

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3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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