Tag Archives: mdds

Full Cycle Teams in a FDA regulated setting

Posted on January 4, 2021 by Bob

The 200X hot topic was Agile development in a FDA regulated setting. Over a decade later this should (hopefully) be a settled issue. I can’t imagine anyone still doing water-fall these days. The new challenge for medical device companies is … Continue reading →

Posted in Agile, FDA | Tagged , , , | Leave a comment

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

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