Looking Forward to Teaching Our 62304 Course

FDA Questions

I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731

For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between the “Software Validation” course and the 62304 course.  In the Software Validation course, the focus is on what does the FDA require and what has the FDA said about software validation. In the 62304 course, the focus is on what can I actually do to solve the problem and to be compliant. The great thing about this course is that instead of just saying “here is what is required,” I can freely share my thoughts on actual solutions.

I have actually been involved with IEC 62304 from its beginning as an AAMI Software Committee Project. That original project was focused on creating the first of its kind – a specific “Medical Device Software Standard” – that was published in 2001 as AAMI SW 68. I guess we must have done something right because before you knew it, the “international” community was saying “can we have an international version of that?”   That was the beginning of the 62304 journey. I still remember all of those great conversations that we had as we worked through the process of converting and adapting the original US National Standard AAMI SW68 into the fully mature, recognized and harmonized standard that it is today.

I was a co-chair in the original 62304 effort. Along the way I was extremely fortunate to have as my partner (the other co-chair) a gentleman named “Sherm,” a.k.a., Sherman Eagles from Medtronic (now with SoftwareCPR). We learned many things together as we designed and developed the standard. Sherman taught me many important lessons along the way. He taught me that this standard needs to the voice of the medical device industry and not FDA-centric.  I think we accomplished that. He also taught me that we need to move beyond the typical FDA responsibility of defining what needs to be done and instead focus on how to implement a workable and useable solution.  I think we accomplished that too.  Sherm also convinced me that the FDA words “software validation” are confusing to the industry and should not be included in the Medical Device Software Lifecycle. You may have never noticed, but there no definition of software validation in the standard and there is no section title “software validation.”  In the end, I believe we created a highly successful standard without using the FDA key word “software validation.”

These days Sherm and I are partners again – this time we are consulting partners at SoftwareCPR.

I am looking forward to the discussion and interaction in Sunnyvale.

More course info at: 62304/FDA Public Training Course, Sunnyvale, CA – Feb 4 -6, 2020

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
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  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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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)

Next public offering:  TBD

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