Connected Medical Device Design

The Design Requirements and Agency Expectations for Connected Devices

The design of wireless medical devices needs to include aspects of system design which are not always obvious. The FDA document Guidance for Industry and Food and Drug Administration Staff Document issued on August 14, 2013, is an excellent starting point for identifying design aspects of a wireless system that must operate and ‘co-exist’ with other diverse devices as well as multiple instances of itself.

Using Agile In Medical Device Development

The FDA Agile Practices In Medical Device Development Under IEC 62304

Agile methods are state-of-the-art for software developers and they can be adapted to IEC62304 in the highly regulated medical device field. The Association for the Advancement of Medical Instrumentation (AAMI) has issued a Technical Information Report, TIR45 Guidance on the use of AGILE practices in the development of medical device software