Clinical Safety

You are working with a team led by the author of the standards, not a consultancy that has learned to interpret them second hand. DCB 0129 and DCB 0160 are NHS England’s clinical risk management standards for health IT, and they set the bar for anyone building or deploying digital health technology in the UK. They align closely with international medical device norms, and DCB 0129 in particular can be demanding for manufacturers meeting it for the first time. That is precisely the ground our team works on every day.

For NHS providers and commissioners, the obligation under DCB 0160 sits with the healthcare delivery organisation, not the individual practice. We build ICB and PCN level safety cases that bring an entire estate into scope through a single engagement, rather than a document per site. This is the model we ran across 11 ICBs, supporting more than 125,000 referrals with zero adverse events.

ETHOS was founded by Stuart Harrison, the author of the NHS clinical safety standards DCB 0129 and DCB 0160, who continues to lead their development internationally. Our approach is built to respect and strengthen your product development lifecycle, and to build confidence and competence within your team, which is your most valuable asset.

Our Clinical Safety Officers are qualified, practising health professionals, including nurses and AHPs, who work alongside your team, systems and processes. The aim is practical solutions that fit your day-to-day operations and build a culture of safety that reassures your customers and end users.

Our work spans DCB 0129 and DCB 0160 audit and review, Clinical Risk Management Systems and Plans, Clinical Safety Case Reports, and the integration of DCB 0129 into medical device Quality Management Systems. We also provide NHS compliance strategy, digital assessment submissions, and support through tender and procurement.

ETHOS is committed to understanding your immediate needs and building a roadmap to guide your compliance work. We work actively with regulatory and professional bodies to advance best practice across health and care, keeping our clients at the forefront of clinical safety and effectiveness.

Allow us to assess your most immediate needs and develop a roadmap to support your compliance work requirements. We’ll also collaborate regularly with regulatory bodies and professional standards organisations to influence best practice across the health and care sector.

Contact us today for your free initial diagnostic conversation or Health Check when you get in touch.