Blog

Timely, insightful, and relevant thoughts, opinions, and discussion on FDA software validation, 62304 compliance, medical device software standards, updates impacting medical device and HealthIT software development, and sundry subjects from our Partners and staff.

In September 2022, FDA Updated the Software Guidance Policy for Device Software Functions and Mobile Medical Applications.  Last revised in September 2019, the policy is intended to clarify FDA’s regulatory oversight on software functions, including those used on mobile platforms and general-purpose computing platforms as well as software in the function or control of a...
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On November 15, 2022, I had the pleasure to log in to a “live” FDA CDRH Industry Basics Seminar on Understanding Risk with Medical Devices.  You can view the workshop at this link: https://fda.yorkcast.com/webcast/Play/4aecf454d2d54039a1d5a6a3001d78c31d I did enjoy the materials presented and I do think the presenters Joseph and Tonya did a great job. I would recommend...
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FDA Updates Cybersecurity Playbook for Health Care Organizations The healthcare sector knows how to prepare for and respond to natural disasters. It is less prepared, however, to handle cybersecurity incidents, particularly those involving medical devices.  With healthcare-related cyber incidents growing in size and scope, preparedness before a cyber event takes place with a strong, well-exercised,...
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Just a few thoughts on metrics … specifically software metric.  A software metric defines a standard way of measuring some attribute of the software development process or an attribute of a software component. A software metric allows us to compare and evaluate one process or component with another, and plan to improve quality of a...
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A course dedicated to “SaMD Risk Management Training?” Yes and much more! More discussion on Risk Management Training between our General Manager, Brian Pate, and our Partner, Dr. Peter Rech, regarding our January 2023 public training course on the application of ISO 14971 and IEC 62304 to system risk analysis and software risk analysis.  Our...
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I recently spoke with Dr. Peter Rech about the 2019 update to ISO 14971 as he and I prepare for our upcoming public training course on January 9-11, 2023, in Tampa, Florida USA.  Registration information can be found at this post: 14971 Risk Management Training Course If you would like more information on applying IEC 62304...
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In September 2022, the FDA Software Precertification Pilot Ends, or has officially “completed” the Software Precertification (Pre-Cert) Pilot Program.  See: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program?utm_medium=email&utm_source=govdelivery The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of...
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What are non-device software functions according to the FDA?  The 21st century cures act excluded certain types of software.  The term device, as defined in section 201(h), shall not include a software function that is intended— (A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or...
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Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...
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This March 2022 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices.  In addition to information on existing standards, our report keeps you...
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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:

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

 

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