Tag Archives: iec 80001

Networked Medical Devices

Posted on December 20, 2008 by Bob

If you work with networked medical devices, Tim’s post Medical Device Networks Trouble Industry is a must-read. In order to better illustrate the bigger picture I thought this diagram might help: This summarizes the relationship between the major players involved … Continue reading →

Posted in Medical Devices, Networking | Tagged , | 2 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