Quality Injection Podcast – Brian Pate

Brian Pate - Quality Injection Podcast

On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input.  Some of the questions they explored were

  • Is a concept phase needed for defining the product or device that meets the user needs.
  • Are validation activities needed to be done during this phase (e.g., preliminary risk analysis)?
  • Why is a System Requirements Specification needed?
  • Who is the intended audience for System Requirements Specification?
  • Which information belongs in a system requirement?
  • What are the Software Requirement Specifications? Who should write them?

The Quality Injection podcast brings out the impact of system requirements on software development and test development as these high level requirements drive:

  • software development planning
  • software risk analysis
  • software requirements generation
  • design verification planning and design validation planning
  • design review activities
  • and more

Understanding and clarifying design input can have tremendous impact on both software development and the overall success of your medical device project.  In addition to the Quality Injection podcast, see our other posts on this important topic:

The Essence of Design Input

Product requirements vs Software requirements

FDA Expectations for Requirements

An Intro to Medical Device Clinical Studies

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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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