Expert oversight, on demand

Ongoing CSO services

Ongoing CSO expertise to embed clinical safety into delivery, support releases and maintain regulatory confidence as you scale.

Trusted by visionary companies building transformative health technologies

Why you might need this

Clinical safety accountability increases as products scale, release cycles accelerate and regulatory scrutiny grows. Ongoing CSO services are often needed for teams:

  • Accelerating their release cycles
  • Training a new CSO
  • Integrating advanced AI
  • Building high risk products
  • Preparating for audit
  • Building a robust compliance culture

Ongoing CSO services

A retained service that keeps you safety compliant through product updates & incidents via named CPO services or support for your internal team.

This service is offered in one of two ways:

Named CSO service

A dedicated Clinical Safety Officer for your organisation, filling expertise or bandwidth gaps so you can keep your product safe and DCB assured. 

Your named CSO takes responsibility for maintaining DCB0129 compliance for one or more products, providing ongoing oversight as your product evolves.

What’s included:

  • Clinical safety ownership
  • Governance & decision-making
  • Risk and incident oversight
  • Release sign-off (CATR)
  • Regulatory interface

What this enables:

  • Faster, safer product builds
  • Continuous compliance
  • Clear accountability
CSO support on demand

Expert support on demand for your internal CSO, giving them the confidence and backing to manage compliance across complex or multiple digital health technologies.

What’s included:

  • On-demand advice
  • Complex feature support
  • Documentation review
  • Incident input
  • Second opinion

What this enables:

  • Reduced bottlenecks
  • Increased confidence
  • Scalable safety function
  • Fast upskilling of your safety team

What you can expect

Whether you choose a named CSO or support for your existing one, both services cover:

Incident reviews
Maintenance of DCB0129 through product updates
DCB0160 support (required by NHS customers for adoption)
Annual governance review meeting (named CSO service only)
Dedicated time every month

Why Curistica?

Ecosystem expertise

We work across healthtech and care delivery, so understand both how products are built and how they are actually used, and what your customers need from you.

Product-informed

We’ve built healthtech products ourselves, so know how to use compliance as an enabler and accelerator, not a blocker.

Care & optimism

We care about the future of digital health, and bring energy and creativity to solving problems, not slowing you down.

Peer-reviewed research

We co-author peer-reviewed research assessing NHS digital health technologies

Right-size compliance

We right-size compliance: pragmatic, proportionate, and defensible - prioritising real risk over paperwork and performative controls.

Regulatory confidence

We help you meet regulatory and compliance expectations with confidence, producing work that stands up to scrutiny from partners, buyers, and regulators.

Working with Curistica has been invaluable. As our independent Clinical Safety assurance partner, they provide a level of rigour, insight, and reassurance that allows us to confidently trial and implement new technologies.
Dr Amar Ahmed
,
GP Partner, Wilmslow Health Centre

How can we help?

Book a call to discuss your clinical safety needs and how we can best support your team, in 20 minutes

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CSO services

FAQs

Does every practice need a CSO of their own?

Each organisation must have access to a named CSO to manage clinical safety activities, but this does not need to be a dedicated individual per practice. The role can be shared across organisations or provided externally.

My practice can't afford a CSO? Can you serve our PCN instead?

Yes. We can act as CSO across multiple practices within a PCN, providing a cost-effective and consistent approach to clinical safety.

What training does a CSO need?

A CSO must be a suitably qualified and experienced clinician. This includes completing recognised clinical safety training and having sufficient technical understanding of the systems being assessed. However, training is only a minimum requirement; effective clinical risk management also depends on experience and the ability to make sound judgements, often developed under the guidance of a more experienced CSO.

What is a Clinical Safety Officer (CSO)?

A Clinical Safety Officer (CSO) is a suitably qualified and experienced clinician, registered with a professional body (e.g. GMC, NMC, HCPC), who is responsible for overseeing clinical risk management for digital health technologies. They must have completed recognised training, have the expertise to assess and manage clinical risk in practice, and have authority within the organisation to ensure DCB0129 processes are implemented and maintained.

Does our organisation need a CSO?

Yes, if your healthtech product is intended for use within the NHS or or publicly funded adult social care. Much like a Data Protection Officer (DPO), your organisation must have a named Clinical Safety Officer (CSO) responsible for overseeing clinical safety activities, including product updates and incident management. This is required to meet NHS clinical safety standards under Section 250 of the Health and Social Care Act 2012. The role can be outsourced if needed.