Medical Device Interoperability Workshop
The purpose of the workshop is to facilitate discussion…on issues related to safe and effective interoperable medical devices.
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.
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.
Cisco Changing to Support Health Care
More surprising, Cisco has submitted the 7921 wireless handset as a Class I medical device.
What’s Wrong with the Proposed FDA MDDS Rule
It is foreseeable… that an MDDS could initiate a command to a medical device that results in unintended operation of the device.
IEC 80001 - An Introduction
The intent of this standard is the application of risk management to enterprise networks incorporating medical devices.
