Every clinical incident in one place
Keep a complete log of clinical incidents, with each one’s status, severity, investigation and outcome visible at a glance, from first report through to closure.
Clinical incidents
tracked from
start to finish
One place to log, investigate and resolve clinical incidents, linked to the relevant hazards, controls and releases.
- Add or link a hazard to an incident
- Sync incidents from other systems via integrations
- Generate incident reports and automate audits
Trusted byclinical safety teams
Features
Best-in-class incident management
Raise incidents from anywhere, and know straight away
Staff can report incidents through the Staff Portal, external stakeholders through your Trust Centre, and AI assistants such as Claude or ChatGPT through the Assuric MCP. New reports trigger notifications by email, in-app and in Slack, so the right people can act straight away.
Investigate and record every reporting decision
Investigate each incident to the right standard, record root cause analysis, and assess whether it meets any relevant reporting threshold (such as MHRA).
Add or link hazards from any incident
Link an incident to the hazards it affects in your hazard log, or add a new hazard straight from the incident, so every investigation feeds back into your clinical risk and keeps it current.
Sync incidents from the tools you use
Incidents sync automatically from tools such as incident.io and our other integrations, logged against the relevant hazards and controls rather than sitting in a separate system.
Incident reports and audits, generated for you
Generate incident reports in a few clicks, and let automation pull incident data into your audits and reviews, so trends and actions are ready when you need them.
Benefits
The difference Assuric makes
Ready before you need it
The worst time to design an incident process is during an incident. Yours is set up and ready to go, with clear reporting thresholds.
Learn from every incident
Root cause analysis, corrective actions and linked hazards turn each incident into a lesson, so the same issue doesn’t happen twice and patient safety keeps improving.
Spend less time on manual work
Incidents sync from the tools you already use and reports are generated for you, so your team spends its time investigating, not chasing and copying data.
Be audit-ready all year round
A complete incident log, with closed investigations, recorded decisions and linked hazards, is exactly what an assessor wants to see, and it’s always up to date.
Build trust with buyers and partners
Stakeholders can report incidents through your Trust Centre, see them acted on and hear the outcome, showing NHS buyers and partners a responsive, mature approach to clinical safety.
Trusted by healthtech’s very best
“We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!”
Maks Kozarzewski
COO, VitVio
“The Assuric platform is a game changer in the clinical risk management field. It has been carefully designed to make the job of a CSO significantly more streamlined. The team are excellent and responsive to any product suggestions I have requested, and it has been a pleasure to work with them.”
Paul Llewellyn
CCIO, Accenture
“Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!”
Katie Baker
Director UK & Ireland, Tandem
Frequently asked questions
Any event involving your product that affected, or could have affected, patient care, whether or not harm actually occurred. That includes software faults, but also misuse, human error, and workflow or configuration issues. If you are unsure, log it and triage it alongside your clinical safety officer.
An incident is an event that affected, or could have affected, patient safety. A complaint is someone’s expression of dissatisfaction. One event can be both, and Assuric lets you manage incidents and complaints in the same place.
Yes. DCB0129 and DCB0160 both expect you to monitor your product once it’s deployed (post-deployment monitoring) and feed safety incidents back into your clinical risk management.
Only if the incident meets the MHRA reporting threshold, which depends on severity and on whether your product is a registered medical device. Incidents that fall below it still belong in your record for post-market surveillance, and Assuric records each decision and its reasoning so it can be reviewed when needed.
Staff can report through the Staff Portal, external stakeholders through your Trust Centre, and AI assistants through the Assuric MCP. Incidents can also be imported automatically from tools such as incident.io through our integrations. New reports trigger notifications by email, in-app and in Slack, so the right people can act straight away.
Your internal team, alongside your clinical safety officer. They look at the impact of the incident, record the root cause and agree corrective actions or controls to prevent it happening again, with any affected hazards updated in your hazard log.
No. The main purpose of the incident log is to show that every incident is logged, investigated and acted on in line with the DCB standards. An empty log is more likely to raise questions than a full one.
Talk to our team of
clinical safety experts
See how Assuric can help you manage your incidents, investigations, hazards and more, all in one place.