AAMI Standards Conference Software Session 2005

AAMI Standards Conference Software Session 2005 including 4 FDA presentations
The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005

Review of Software in Premarket Submissions (new guidance for CDRH and CBER)
– David S. Buckles FDA CDRH ODE
Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software
– John Murray FDA CDRH Office of Compliance
Computerized Systems Used in Clinical Trials – Draft Guidance [9/04]
– Patricia Beers Block FDA Office of the Commissioner
AAMI TIR32:2004 Medical Device Software Risk Management – Purpose & Scope March 2005
– Paul Jones – FDA CDRH OSEL
AAMI TIR32:2004 Medical Device Software Risk Management – Content Overview & Status March 2005
– Alan Kusinitz SoftwareCPR®
Risk Management in IEC 62304 CDV
– Sherman Eagles Medtronic

Upcoming SoftwareCPR Training Courses:

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.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 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


Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:



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