Noice debugger repuation software#
We have investigated hundreds of medical device software defects over the years and have come to appreciate a structured mental framework for tackling difficult bugs.
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Why not have a schema for debugging? Wouldn’t it be nice to quickly load another engineer’s debugging state into your brain?Ī thorough and well-documented defect-review procedure is required by medical-device regulations, including the US quality systems regulation (21 CFR Part 820 subpart I) and ISO 13485 section 8.2.2. When it comes to organizing information, debugging patients and debugging software are similar. It is sort of like an API that healthcare providers use to transfer state when they speak to each other. The standardized schema facilitates safe handoffs and fast patient-record review. Need to know why the team made a decision for a critical care patient? That is in the “assessment and plan” section. Need to know if the patient smokes? That is in the “social history” section. A patient’s medical history has a universally accepted schema that allows physicians to quickly review a medical history. Physicians have been concerned about portability well before the digital age. Why all the fuss about portability? It can save lives. Pop quiz: What does the “P” in HIPAA stand for? Privacy? Protection? Patient? It actually stands for “Portability”.
The medical diagnostic process is similar to software debugging in many ways:
Not only is a documented procedure for evaluating complaints required by the regulations, but it is also a good engineering practice. We have used the approach for several years on client projects, including an industry leading medical-device company with hundreds of installations around the world and a multi-tiered support organization. This document details the SKUASH debugging methodology for medical device software defect investigation and documentation. While quality metrics can vary from organization to organization, we can all agree that timely and thorough defects resolution should be one of them.
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“Rubber ducking” is the practice of talking to inanimate objects to think through bugs.Īre you curious about how to resolve defects in regulated medical device software? Are you working on a defect resolution process for your own company? If so, this article is for you.Ī key component of any ISO 13485 compliant quality management system (QMS) is a defect resolution process. A Method for Debugging Medical Device Software
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