Category Archives: FDA

FDA

Validation of Off-The-Shelf Software Development Tools

Posted on November 12, 2011 by Bob

A reader asked me about OTS software tool validation. He says: It seems to me that the editor and any other tool used to create the software is exactly that, a productivity tool. The end result (compiled binary installed on a … Continue reading →

Posted in FDA | Tagged , | 12 Comments

Open Source Medical Device Connectivity

Posted on October 2, 2011 by Bob

In The Case for Open Source Healthcare IT John Zaleski uses the VistA open source software as a model for improving the medical device data gathering in order to produce a “more robust end product”.  On the whole, I could not agree more. Achieving … Continue reading →

Posted in EMR, FDA, Interoperability, Medical Devices | Tagged | 6 Comments

Third Annual Medical Device Connectivity Conference

Posted on August 14, 2011 by Bob

This year’s Medical Device Connectivity Conference is less than a month away. It’s being held Sept. 8-9, 2010 in Boston. In addition to the post-conference workshops, there is also a special preconference event: an open house at the Medical Device Plug and … Continue reading →

Posted in FDA, Interoperability, Medical Devices | Tagged , | Leave a comment

Discomfort with Computerized Medical Devices

Posted on April 11, 2011 by Bob

Here are some thoughts regarding the article: I feel a little uncomfortable about computerized medical devices, and here’s why. Just about all medical devices are computerized these days. Most will not harm or kill you if their software fails (Class … Continue reading →

Posted in FDA, Medical Devices, Software Quality | Tagged | 1 Comment

Personal Healthcare Products: This is what the future looks like.

Posted on January 4, 2011 by Bob

I’m jealous of companies that get to produce diagnostic medical devices without having to go through the FDA 510(k) process. For example, the iHealth BP3 blood pressure monitor is a high-tech looking device with a  free Apple application: Hopefully they’re using … Continue reading →

Posted in FDA, Medical Devices | Tagged | 2 Comments

Agile Software Development in Regulated Environments

Posted on October 16, 2010 by Bob

As part of a series on High Assurance Agile Development in Regulated Environments is the article Agile Software Development in Regulated Environments Example: Medical Devices. The purpose of this article and future posts is to introduce the FDA regulatory landscape and … Continue reading →

Posted in Agile, FDA, Software Quality | Tagged | 3 Comments

Technical Debt in Medical Software

Posted on August 4, 2010 by Bob

Software development is software development. Most of the life cycle and quality issues faced in medical software are the same challenges for any software product. Technical Debt in Medical Software points out what technical debt is: Complexity Code Duplication Documentation … Continue reading →

Posted in FDA, Programming, Software Quality | Tagged , , | 2 Comments

ISO 62304: The Harmonized Standard for Medical Device Software Development

Posted on June 5, 2010 by Bob

The FDA approved ISO 62304 as a recognized software development standard in 2009. Developing Medical Device Software to ISO 62304 gives a nice overview. Besides providing a globally accepted development process one of the other practical components is the assignment … Continue reading →

Posted in FDA, Medical Devices, Software Quality | Tagged | 7 Comments

The Software Quality Balancing Act

Posted on May 15, 2010 by Bob

Andrew Dallas’s article Caution: V&V May Be Hazardous to Software Quality touches on a number of good points regarding software quality best practices. Medical device software development V&V (also see here) and the documentation that goes with it have substantial … Continue reading →

Posted in Agile, FDA, Medical Devices, Software Quality | Tagged , | 1 Comment

To Validate and Verify: Software Issues Solved

Posted on April 6, 2010 by Bob

Yours truly was interviewed for this article: To Validate and Verify: Software Issues Solved “V&V” is one of those topics that should be simple to understand, but for some reason is the source of a lot of confusion. This is … Continue reading →

Posted in FDA, Software Quality | Tagged | 1 Comment