Category Archives: FDA

FDA

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

Medical Device Software Development – Going Agile

Posted on October 14, 2007 by Bob

I’ve been involved in some informal discussions regarding the use of Agile methodologies for medical device software. The Medical Device and Diagnostic Industry (MD&DI) October 2007 article by Tim Bosch entitled Medical Device Software Development—Going Agile provides a good overview … Continue reading →

Posted in Agile, FDA | 2 Comments

CardioDynamics Receives FDA 510(k) Clearance for Innovative Clinical Parameters and Electronic Medical Record Compatibility

Posted on September 30, 2007 by Bob

CardioDynamics International Corporation (CDIC) Receives FDA 510(k) Clearance for Innovative Clinical Parameters and Electronic Medical Record Compatibility. WooHoo! Congratulations to all of the CDIC R&D (including yours truly) and Quality teams for getting this done. Great job everyone!

Posted in EMR, FDA, ICG | Leave a comment

Software Defects and the FDA

Posted on August 25, 2007 by Bob

I ran across this post: Why Making Software Companies Liable Will Not Improve Security. It’s a rather long piece that discusses the liability of software makers for security breaches. In the middle of the article he talks about his experience … Continue reading →

Posted in FDA, Software Quality | Leave a comment

Update: Agile development in a FDA regulated setting

Posted on July 25, 2007 by Bob

I contacted Frank Jacquette regarding my previous port on this subject (Agile development in a FDA regulated setting). His experience using Agile methodologies for pure software medical device projects does not correspond with my conclusion regarding cost effectiveness and regulatory … Continue reading →

Posted in Agile, FDA | 3 Comments

Agile development in a FDA regulated setting

Posted on July 22, 2007 by Bob

I ran across an interesting Agile v. FDA discussion the other day. For those that are not familiar with what a FDA regulated product means, I’ll give a brief overview. In order to market and sell a medical device in … Continue reading →

Posted in Agile, FDA | 18 Comments