Every signal from the field, in one record
Bring incidents, complaints and user feedback out of support inboxes, spreadsheets and call notes into one surveillance record, so your team reviews everything in one place.
Post-market surveillance
that keeps pace
Bring incidents, complaints and feedback into one surveillance record, link what you learn to your risk file and prepare the PMS reports your device class requires.
- Incidents, complaints and feedback in one record
- Link to your risks, CAPAs, change requests
- Automate PMS reports for your device class
Trusted byquality teams
Features
Everything from the field,
in one record
Vigilance decisions, recorded either way
Assess each incident against the MHRA and EU MDR vigilance criteria, and record the decision and the reasoning behind it, including when an incident doesn’t need to be reported.
Spot trends before they become incidents
See complaint and incident trends over time, so a rising pattern is caught early and acted on, not discovered at your annual review.
Turn what you learn into action
Link findings to the risks they affect and flag them for review, then raise CAPAs and change requests from the same record.
Field safety actions, fully traceable
Record field safety corrective actions and field safety notices, linked to the incidents, risks and releases behind them, so every action can be traced from signal to resolution.
PMS reports for your device class, automated
Generate post-market surveillance reports from your live data, in line with your device class and on the schedule it requires, instead of compiling a year of records by hand.
Benefits
Keep your post-market surveillance on track
Spend less time on manual work
One surveillance record and automated PMS reports take care of the repetitive work, so reporting takes minutes, not a month of compiling.
Catch issues early
Trends and linked risks surface problems early, so you act before an issue becomes a field safety action.
Know where you stand on every incident
Every incident, reporting decision and the reasoning behind it is on record, so your team can explain what happened and why.
Be audit-ready all year round
Surveillance records, decisions and reports are always up to date, so a review is a look at what’s already in Assuric, not months of piecing together.
One system from design to post-market
PMS sits alongside your QMS, risk file and technical documentation, so what you learn in the field flows straight back into the product.
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
Mapped to other frameworks
Overlapping requirements and evidence are mapped across frameworks automatically, so you never do the same work twice.
Frequently asked questions
The process of actively collecting and reviewing information about your device once it is in use: incidents, complaints, user feedback and literature, and acting on what it tells you. It is a requirement under UK MDR and EU MDR.
Yes. The obligation applies across classes, and the depth and frequency of reporting scale with classification.
Serious incidents that meet the reporting threshold, significant adverse trends, and field safety corrective actions. Incidents below the threshold still belong in your surveillance record, with the decision documented, which Assuric records for every incident.
PMS reports for your device class, including the post-market surveillance report for Class I and PSURs for Class IIa and above, generated from your live surveillance data.
Findings link to the ISO 14971 risks they affect and flag them for review, and you can raise CAPAs and change requests from the same record.
Yes. FSCAs and field safety notices are recorded and linked to the incidents, risks and releases behind them.
Complaint and incident trends are tracked over time, so a rising pattern is caught early rather than at your annual review.
Stay on top of
post-market surveillance
See your QMS, risk file, technical documentation and PMS file working together.