Medical devices, UK
How we cleaned up assessment records for a UK medical device CAB
We put Acuitic Certify in place for a UK Conformity Assessment Body — approvals and findings out of email and PDFs into one auditable workspace — clearer trails for surveillance audits, and enough credibility to bid for more regulated clients.
Who they are.
This UK Conformity Assessment Body focuses on medical device conformity work under UKCA/CE and related schemes. About ten technical staff and a small office team handle on the order of 100–150 active assessments a year for startups through mid-size manufacturers. The technical work was solid; the documentation and client communication were not.
Where processes broke down.
Assessment decisions sat in email threads, Word docs and scanned signatures. For one surveillance audit they spent the better part of a week reconstructing how a single assessment had been approved.
The auditor raised multiple findings around objective evidence of approvals and traceability of assessment records — enough to force corrective actions and put pressure on accreditation.
Clients had little visibility while assessments ran for weeks. The office answered the same “where is our report?” messages every day. Larger pharmaceutical and device buyers increasingly asked how the CAB controlled its own processes — a bar this team could not show clearly.
Before
- Several documentation findings on the last surveillance audit
- Days spent rebuilding approval history from email
- Almost no client visibility into assessment status
- Slow replies while staff hunted for the latest PDF
- Hours each day on status chasing
- Hard to win work that demanded proven digital controls
After
- No major documentation findings on the following surveillance audit
- Assessment packs ready to show from the system in hours, not days
- Clients see status and next steps in a portal
- Most status questions answered without a phone call
- Office time freed for onboarding and follow-up assessments
- A small set of regulated clients signed in year one (~€90K)
What Acuitic Certify changed.
We set each assessment up in one workspace: summary, risk notes, plan, findings, corrective actions and sign-off. Files and decisions stay versioned with who changed what and when.
Approvals move Technical Lead → QA → Director inside Certify. Approvals, change requests and rejections are recorded on the record — not reconstructed later from email.
Clients get limited portal access for status and document upload. Reports generate from the assessment data with digital signatures and a clear approval history.
A few months after we went live, through their next surveillance cycle.
Illustrative figures — not verified client metrics.
Surveillance audit. Documentation findings that had driven corrective actions the year before did not repeat. The auditor could follow approvals in the system.
Prep time. Evidence pulls that used to take days now take a short session exporting trails and opening assessment records.
Client experience. NPS moved from the mid-50s into around 70, largely from clearer status and fewer “still waiting” emails.
Market access. They closed four regulated assessments in year one worth about €90K — work they previously struggled to win on process credibility alone.
Office load. Status chasing dropped enough that the small office team could spend more time on onboarding and follow-ups.
Our last audit hurt because we could not prove the approval chain cleanly. Certify put every assessment in one place with a trail we can open in minutes. That is what let us walk into the next surveillance with confidence — and talk to more demanding clients without hedging.
ROI and payback.
Illustrative financials — not audited or client-confirmed.
| Implementation & configuration | GBP ~18,000 |
| Year 1 platform license | GBP ~13,000 |
| Surveillance prep time saved | GBP ~6,000 |
| Office time saved on status chasing | GBP ~9,000 |
| New regulated assessment revenue | ~€90,000 |
What changed in the market.
- Credible digital trails. They can show controlled assessment workflows when buyers or auditors ask — not a folder of emails.
- Access to pickier buyers. Process transparency unlocked a slice of regulated work that used to go elsewhere.
- Lower audit stress. Fewer documentation findings means less corrective-action overhead between cycles.
- Clearer client communication. A simple status view reduces the black-box feeling around long assessments.
- Knowledge stays in the system. Decisions are not trapped in one person’s inbox if someone leaves.
Where they go next.
- NextCorrective-action follow-up
Track client corrective actions and re-assessment dates in the same workspace.
Config + light portal work - LaterRicher report templates
More scheme-specific report packs without leaving Certify.
Template work with Acuitic - LaterRegulatory reference links
Point assessment templates at current guidance pages to cut planning time.
Incremental
Running certification or inspection the hard way?
Request a demo of Acuitic Certify, or book an intro call.