Clinical Risk Management Plan
Written for your product and your development process, rather than a template with your name substituted in.
Named appointment
Clinical Safety Officer.
If you are building health IT or Software as a Medical Device for use in the NHS, you cannot deploy without an appointed Clinical Safety Officer. It is a personal appointment held by a named clinician, not something a firm can hold, so I take it as an individual.
What you get
The file, and the person who signs it.
Hazard log, built from the real workflow
Hazards identified against how the product is actually used under time pressure, not how the user manual assumes it is. Interface-induced use error (IEC 62366) is treated as a hazard, because that is what it is.
Hazard workshops with your team
Run with engineering and product together, so that mitigations get designed into the build rather than documented around it afterwards.
Clinical Safety Case Report
The argument a reviewer actually reads, with the DCB0160 counterpart where a deploying organisation needs its own.
Ongoing safety across releases
The file is a living document and reviewers know it. Sign-once-and-leave is how a safety case goes stale before the second release ships.
The requirement
It is not optional, and it is not a formality
DCB0129 puts the obligation on the manufacturer and DCB0160 on the organisation deploying. Both require a named Clinical Safety Officer: a suitably qualified and experienced clinician, registered with the relevant professional body, who owns the clinical risk management file and signs the safety case. Without one you have no safety case, and without a safety case you will not clear DTAC or get through an NHS organisation's own assurance. It is one of the more common places a product with a CE-Mark still stalls.
The obligation
DCB0129 makes the health case explicit: a measurement that can mislead a clinical decision is a hazard, and an unlogged hazard is a gap in your safety case. The same evidence logic sits behind every regulatory shape it takes: a Clinical Evaluation Report for CE-Mark, an FDA submission for Software as a Medical Device (SaMD), a safety case for the MHRA. Different documents, one obligation. Outside healthcare there is no equivalent standard, only a number that drives a selection, training, or deployment decision. The obligation to know it is real does not change.
A hazard does not have to come from the sensor. A number can be perfectly valid and still be shown at the wrong moment, next to the wrong patient, or in a way that reads one way at a glance and another on inspection. Usability engineering for medical devices (IEC 62366) treats that as a use error rather than a user error, and it is the mechanism behind a large share of the tools that pass the bench and fail in service. We look at the signal and the interface together, because in practice they fail together.
Clearing a regulator is not the same as making a sale. In the UK the gates that actually decide whether an NHS organisation can buy you are the NICE Evidence Standards Framework for digital health technologies, which asks what your evidence proves and at what tier, and the Digital Technology Assessment Criteria (DTAC), which asks whether you can be adopted safely at all. Both are answered with the same evidence, and both are where products with a CE-Mark still stall.
When people call
You probably need one if:
- You are preparing for DTAC and have been asked for a clinical safety case
- You are about to deploy into an NHS organisation for the first time
- Your previous Clinical Safety Officer has left and the file has stalled
- You have a hazard log that was written once and never revisited
- An investor or acquirer has asked who signs your safety case
Before you ask
One seat per company.
Metriqx does not conduct investor diligence on companies it advises, and does not offer advisory to companies it has assessed on behalf of a third party. Assessment and advisory are separated by client, not by project.
If you are not sure which seat you want us in, that is a reasonable thing to work out on a call before anyone commits. What we do is here.
Need a Clinical Safety Officer?
Tell us where the product is and what you are deploying into, and we will tell you what the file actually needs.