ginsbourg.com - presentation of a plan for medical device software validation and verification

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Plan for Medical Device Software Validation and Verification

2014-2015

Ginsbourg.com MD SW V&V 2014-2015 April 8, 2023 1

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April 8, 2023

• Formerly QA Manager of LoadRunner at Mercury Interactive• M.Sc. cum laude in Bio-Medical Engineering• M.Sc. in Mechanical Engineering

2Ginsbourg.com MD SW V&V 2014-2015

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April 8, 2023 3Ginsbourg.com MD SW V&V 2014-2015

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1. Coding finished2. Run a few tests3. System approved4. Release

Result: Disaster ! Inadequate design or poor

coding produces many time bombs in the system!

← High Risk Approach


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Therac-25 medical accelerator (1985-1987)

• Therac-25 was a therapy system that delivered two different kinds of radiation: either a low-power electron beam or X-rays.

• The Therac-25's X-rays were generated by smashing high-power electrons into a metal target positioned between the electron gun and the patient.

• An electromechanical safety interlock was replaced by a software control, because software was perceived to be more reliable.

• The OS was compiled by a programmer with no formal training. • Because of a “race condition” bug, the operator could accidentally configure the

Therac-25 so the electron beam would fire in high-power mode, but with the metal X-ray target out of position.

• At least five patients died; others were seriously injured.

Catastrophic software failure


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"I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA. That is NOT a risk management system."Kimberly A. Trautman, QSR Expert, CDRH, FDA

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QC → ProductsQA → Processes

ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes


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← Low Risk Approach1.SW Lifecycle2.Documentation3.Risk Analysis4.Specifications (functional, performance, usability, etc.)

5.Requirements (marketing, technical, user expectations, etc.)

6.Code Review (manual, automatic)

7.Code Freeze8.Version Management9.Bug Base10.Validation & Verification


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April 8, 2023

What are mobile medical apps?Mobile apps are software programs that run on smartphones and other mobile communication devices.

How will the FDA regulate mobile medical apps?The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.

Last Updated: 10/22/2013


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April 8, 2023

When is a mobile app classed as a medical device?


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April 8, 2023

• Currently available for iOS devices. • Helps doctors calculate the percentage of

a patient’s body surface area that is burned.

• Calculates the amount of fluid to be administered in the 24-hour period that follows the burn injury.


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10-step plan for medical device software validation and verification:

1. Perform risk analysis2. Determine level of concern3. Describe the software4. Formulate requirements specifications5. Develop design specifications inc. architecture design chart6. Craft a software development environment summary document7. Document validation and verification testing8. Perform a traceability analysis9. Determine unresolved anomalies10.Maintain a log of revision and release numbers

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April 8, 2023

http://www.ibm.com


http://www.ibm.com/

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