Medical Device Interoperability Workshop
The purpose of the workshop is to facilitate discussion…on issues related to safe and effective interoperable medical devices.
Standards & Regulatory
FDA Posts New Draft Guidance on Computer-Assisted Detection Devices
While designers of such systems like to say it is “just an aid” and thereby in part try to avoid responsibility for the quality of the output, the likely reality is that it will be relied upon, and therefore a high level of performance should be assured.
Impact of Modifying FDA Regulated Devices
Unfortunately for you, congress did not wish to extend the physician exemption to hospitals.
Canada Posts “Medical Device Data System” Rule
Any software that receives and manipulates patient data is a medical device.
FCC Seeks Comment (Again) on MBANs
The same vague promises of working out an industry standard after the fact were made when WMTS was created.
Medical Device System Network Install Issues
If a medical device system runs on a network (physically separate or as a VLAN on your hospital enterprise network) the network is part of the medical device.
Running Medical Device Software on Shared Computers
The ability to support third party apps on a PC that’s a medical device is highly dependent on the design approach and verification testing used by the manufacturer.
Final MDDS Rule Expected Soon
One should not mistake past regulatory discretion for lackadaisical enformcement on the part of the FDA.
Facing FDA Regulations for the First Time
What are your risks in being part of a regulated device, and what can you do to make yourself a more attractive supplier?
Interoperability - Barriers to Adoption
Gulp. This makes the initial R&D costs seem like a bargain.
