Clinical Safety Officer at work

DCB 0129/0160 and Medical Device compliance
for Digital Health solutions

SCCI 0129 and SCCI 0160 hazard log and safety case development

Experienced and independent Clinical Safety
Officers

On-site clinical safety training courses

Hazard log and Safety Case development
services

Welcome to Safehand

DCB 0129 and DCB 0160 are the UK’s mandatory safety standards for health IT systems and apps. If you manufacture health software or you’re an NHS organisation implementing health software, you need to comply. This website contains lots of information to help you along that journey.

For more information about the standards and how they work, visit our five minute guide or take a look at our blog.

Clinical Safety Officer at work
Let Safehand be your Clinical Safety Officer
Clinical Risk Management Training
Onsite clinical safety training courses
SCCI 0129 and SCCI 0160 hazard log and safety case development
Build a Hazard Log and Safety Case
News
Five things you should do today as a DCB 0129/0160 Clinical Safety Officer
Five things you should do today as a DCB 0129/0160 Clinical Safety Officer
Being a DCB 0129 or DCB 0160 Clinical Safety Officer is an absorbing and fulfilling role. But, at times, it can be a demanding job. For
6 December, 2018
0  Like
Could you be a Medical Device manufacturer without knowing it?
Could you be a Medical Device manufacturer without knowing it?
Did you know that it’s surprisingly easy to be the manufacturer of a Medical Device without even knowing it? Yes, it’s true. Why does
23 October, 2018
0  1
As Low As Reasonably Practicable – What does ALARP really mean in Digital Health compliance?
As Low As Reasonably Practicable – What does ALARP really mean in Digital Health compliance?
The DCB 0129/0160 Standards call for risk to be mitigated to As Low As Reasonably Practicable (ALARP). But what on earth does this mean
31 July, 2018
0  1
DCB 0129 and the Medical Device Directive – One little gap just got plugged
DCB 0129 and the Medical Device Directive – One little gap just got plugged
The regulatory landscape is changing, and a little gap was just plugged. Blink and you probably missed it. Just last year we posted a
19 June, 2018
0  Like
Does your supplier’s Safety Case chime as clear as a bell?
Does your supplier’s Safety Case chime as clear as a bell?
As suppliers of Digital Health systems gradually comply with the DCB 0129 safety standard, healthcare organisations are increasingly
18 October, 2017
0  1

"In completing the work supported by Safehand and its detailed knowledge it has also allowed us to integrate the safety processes in to our existing Quality Management system (ISO 9001/2015) allowing us to better manage the risk of software change going forward.” John Hopkins, Chief Executive of Med eTrax. Read the case study...

Med eTrax April 21, 2017

“There is no doubt in my mind that Safehand’s guidance helped us complete the work faster, and be even more thorough in our approach.” Iain Mackenzie, Clinical Safety Officer, InterSystems. Read the case study...

InterSystems April 21, 2017

Some of Our Clients

Company Information

Safehand Consulting Limited Company number: 10012494 VAT No: 234182721
Copyright © 2016 Safehand. Planted by Mustard Seed Media