Category Archives: FDA

FDA

Why Healthcare IT is Not a Game Changer

Posted on February 15, 2010 by Bob

Last week I attended the WLSA/Continua Mobile Healthcare Symposium and the opening day of the Continua Health Alliance Winter Summit 2010.  Also, a couple of weeks ago I attended a few of the FDA Workshop on Medical Device Interoperability: Achieving … Continue reading →

Posted in EMR, FDA, Interoperability | Tagged , , , , , | 1 Comment

The Challenges of Developing Software for Medical Devices

Posted on February 8, 2010 by Bob

Developing Software for Medical Devices – Interview with SterlingTech gives a good overview of the challenges that especially face young medical device companies. In particular (my emphasis): Make sure that your company has a good solid Quality System as it … Continue reading →

Posted in FDA, Medical Devices, Programming, Software Quality, Tools | Tagged , | Leave a comment

Medical Device Software on Shared Computers

Posted on September 7, 2009 by Bob

The issues raised in Tim’s post Running Medical Device Software on Shared Computers literally opens Pandora’s box. Installation of medical device software on general purpose computers is an intractable problem. It’s very similar to the complications associated with Networked Medical … Continue reading →

Posted in FDA, Interoperability, Medical Devices, Networking | 8 Comments

When Cell Phones Become Medical Devices

Posted on July 14, 2009 by Bob

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data.  The FDA will soon be forced to step in and take regulatory control.  It’s going to happen eventually. Bradley Merrill Thompson does a good job … Continue reading →

Posted in FDA, Medical Devices | 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 →

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Corrective and Preventive Action (CAPA) and the FDA

Posted on March 11, 2008 by Bob

It’s Easy to Get into Trouble Because of CAPA summaries an audio conference on Implementing an Effective CAPA System: What You Need to Know (pdf) sponsored by FOI Services. Creating a corporate culture that can carry out a quality system … Continue reading →

Posted in FDA, Medical Devices | 1 Comment

Medical Device Data System (MDDS) FDA Rule Changes

Posted on February 8, 2008 by Bob

As reported here and here, the FDA is proposing to reclassify a MDDS from a Class III to a Class I medical device. On the surface this might seem like a big deal. If you read the fine print though … Continue reading →

Posted in FDA | 1 Comment