IEC 80001 to Impact Providers
This is an ongoing requirement, and not a one time shot.
IEC 80001 - An Introduction
The intent of this standard is the application of risk management to enterprise networks incorporating medical devices.
Networked Medical Device Study Group Adjourns, Plans Next Steps
It seems that something like the existing ISO 14971 risk management standard for medical device manufacturers will be used to address networked medical devices. Several major revisions will be required, not the least of which is the kind of risk. The potential harm that ISO 14971 tries to mitigate is risk of injury to patients. […]
Study Group Explores Networked Medical Device Risk Management
There were about 25 attendees today; mostly regulatory, quality and security experts along with a few representing hospitals, and a connectologist or two. We ran from 11am until almost 7pm. (You can read my run up to this meeting here.)
As security expert and clinical engineer Steve Grimes noted, we are an industry in transition with […]
Regulatory Bodies Contemplate Regulating the Deployment and Use of Networked Medical Devices
I’m on my way today to an interesting meeting being held at FDA offices in Rockville, MD. The regulatory groups ISO TC210 and IEC SC62A are convening a formal study group to look at safety requirements relating to installation, configuration and maintenance of networkable medical devices. This is a two day meeting and I’ll be […]
