Day

May 5, 2014
This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. Green Paper on Mobile Health
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The following draft standards are being circulated for comment or ballot. More information is availale to Standards Navigator Subscribers in the the Standards Navigator topic:-IEC 62304 Amendment CDV -$ISO 16142-1 DIS -ISO 90003 FDIS -ISO 15289 FDIS -ISO 24748-4 DIS -ISO 24748-6 NP
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This white paper provides an update of the proposed revisions to EU medical device regulation as of April 2014. BSI WP EU Regulations
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Alan Kusinitz Managing Partner of SoftwareCPR accepted appointment to the Biomedical Instrumnetation and Technology journal editorial board. Alan authored a number of articles for this journal and performed peer revieiws for the journal over the years.
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Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/october-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

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