Category Archives: Software Quality

Software Quality

Guest Article: Static Analysis in Medical Device Software (Part 2) — Methodology

Posted on June 4, 2009 by Pascal

Pascal Cuoq at Frama-C continues his discussion of static analysis for medical device software. This is part 2 of 3. Part 1 is here. In the second part of this article I write about methodology, where tools and engineering come … Continue reading →

Posted in Programming, Software Quality | Tagged , , | 4 Comments

Guest Article: Static Analysis in Medical Device Software (Part 1) — The Traps of C

Posted on May 15, 2009 by Pascal

Any software controlled device that is attached to a human presents unique and potentially life threatening risks.  A recent article on the use of static analysis for medical device software prompted Pascal Cuoq at Frama-C to share his thoughts on … Continue reading →

Posted in Programming, Software Quality | Tagged , , | 4 Comments

Software Verification vs. Validation

Posted on March 26, 2009 by Bob

For some reason it just really bugs me that these two terms are incorrectly interchanged so frequently. Part of the problem is that the document General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002) does not … Continue reading →

Posted in FDA, Software Quality | Tagged | 28 Comments

More Software Forensics and Why Analogies Suck

Posted on July 1, 2008 by Bob

There’s a recent article in the Baltimore Sun called Flaws in medical coding can kill which just rehashes static software  analysis (hat tip: FDA Trying to Crack Down on Software Errors). I’ve discussed software forensics tools before. Yes, bad software … Continue reading →

Posted in FDA, Medical Devices, Software Quality | 3 Comments

Connecting Computers to FDA Regulated Medical Devices

Posted on June 18, 2008 by Bob

Pete Gordon asked a couple of questions regarding FDA regulations for Internet-based reporting software that interface with medical devices. The questions are essentially: How much documentation (SRS, SDS, Test Plan) is required and at what stage can you provide the … Continue reading →

Posted in FDA, HL7, Medical Devices, Networking, Software Quality | Tagged , | 2 Comments

The Benefits of Software Validation

Posted on March 24, 2008 by Bob

Many people still confuse verification (was the product built right?) and validation (was the right product built?). The benefits of both of these activities are well covered in Software Validation: Turning Concepts into Business Benefits: Software V&V is a FDA … Continue reading →

Posted in FDA, Software Quality | Leave a comment

Software Development: Driven by what?

Posted on February 17, 2008 by Bob

First a definition: driv·en –adjective : having a compulsive or urgent quality : propelled or motivated by something — used in combination <results-driven> Driven software development methodologies abound: Behavior-Driven Development (BDD) Design-Driven Development (D3) Domain-Driven Design (DDD) Feature-Driven Development (FDD) … Continue reading →

Posted in Agile, Programming, Software Quality | 1 Comment

Understanding Software Defects

Posted on November 25, 2007 by Bob

We tend to focus a lot of attention on tools and methodologies for improving software quality. I thought it would be worth while taking a step back to try to understand what the root causes of software defects are. Fortunately … Continue reading →

Posted in Agile, Software Quality | 1 Comment

Ever heard of FRACAS?

Posted on October 27, 2007 by Bob

FMEA (Failure Mode and Effects Analysis) is a regular part of our development process (we call it “Hazard Analysis”), but I was unfamiliar with FRACAS (Failure Reporting, Analysis, and Corrective Action Systems) until I ran across this: 10/21/2007 FRACAS? – … Continue reading →

Posted in Medical Devices, Software Quality | 2 Comments

Medical Device Software Forensics

Posted on October 17, 2007 by Bob

“The Gray Sheet” has an article called CDRH Software Forensics Lab: Applying Rocket Science To Device Analysis. Can it really be true that CDRH is doing static code analysis for detecting software defects in recall investigations? Static code analysis has … Continue reading →

Posted in FDA, Medical Devices, Software Quality | 4 Comments