Over the years we have written many articles on all matters relating to DCB 0129/0160, safety management and Medical Devices. See below an easy to use index to some of these articles:
DCB 0129/0160 in general
Where to find the Standards
What exactly is Clinical Risk?
DCB 0129 and the Medical Device Directive – One little gap just got plugged
NDAs in Clinical Risk Management
Safety and your organisation
Who’s to blame when things go wrong, the clinician or the ICT?
The role of the Clinical Safety Officer – a poisoned chalice?
Five things you should do today as a DCB 0129/0160 Clinical Safety Officer
Why does risk management in Health IT need to be proactive?
The evolution of safety processes
Are commercial contracts the right way to manage clinical risk?
Writing the DCB 0129/0160 documents
Top tips for writing hazard logs
Safety cases in Health IT – What’s all the fuss about?
Project risk log and hazard log – are they the same thing or different?
“This is a MASSIVE clinical risk!!” – describing defects in health IT
What does ALARP really mean in Digital Health compliance?
The Safehand three-stage approach to evidencing health software testing
Video: Using numbers in risk matrices
Hazards and their evaluation
Is your health IT solution an ugly baby?
Can health IT usability compromise patient safety?
Can workarounds help us to deal with safety-related faults?
The illusion of communication – A silent hazard of Health IT systems
DCB 0160 specifically
Evaluating a supplier's safety case
Assessing systems which are already live
Medical Device Directive/Regulation
Can a healthcare organisation demand that I CE Mark?
Applying a CE Mark without actually doing the compliance work
When should a clinician trust a Medical App?
Five key differences between the Medical Device Directive and DCB 0129
Could you be a Medical Device manufacturer without knowing it?
