UKCA · UK MDR 2002 · ISO 13485 · UK Approved Body
Quality records for UKCA, CE and FDA device routes.
Keep device records, traceability and complaints together.
One set of records
Device records, traceability and complaints for several market routes.
Traceable Lots
Follow each lot from components to dispatch.
Vigilance stays human
Your team decides and submits any vigilance reports.
What goes wrong today3 common problems
Three markets, three sets of evidence
UKCA, EU MDR and FDA each want their own traceability, labelling and post-market records — usually maintained in parallel by the same small RA team.
Device History Records Rebuilt After the Fact
If the DHR is assembled from travellers and spreadsheets at the end, every gap becomes a non-conformity.
Post-Market Data Never Reaches the Design File
Complaints and field data sit in a helpdesk, disconnected from risk management and the technical documentation they should be feeding.
Everything V5 does here5 capabilities
One QMS, mapped to each route
ISO 13485 processes drive the system; UKCA, EU MDR and QMSR expectations are presented as views on the same records rather than separate systems.
Electronic device history record built as it is made
Every component lot, process step, inspection, signature and label is captured in sequence — the eDHR is complete when the device is.
UDI and Labelling Controlled
Label content is generated from approved master data and scan-verified at application, with UDI carriers correct per market.
Complaints, Vigilance and Risk Connected
Complaint intake drives reportability decisions with a recorded rationale, and feeds trend data straight into risk management and CAPA.
Approved Body Audit Readiness
Technical documentation references, batch evidence, supplier controls and training records assembled continuously for UK Approved Body and notified body visits.
Standards Referenced
- UK MDR 2002 (as amended) — UKCA marking
- ISO 13485:2016 / ISO 14971:2019
- MHRA registration and post-market vigilance requirements
- EU MDR 2017/745 for dual-market manufacturers
- 21 CFR 820 / QMSR for US-facing manufacturers
Common questions5 answers
- What is UKCA marking?
- UKCA is the conformity marking for products placed on the Great Britain market. For medical devices it is granted under the UK MDR 2002 (as amended), with conformity assessed by a UK Approved Body for most risk classes, and manufacturers registered with the MHRA.
- Do we need a separate system for UKCA and CE?
- No, and you should avoid one. The underlying ISO 13485 processes, device history records and post-market data are shared; V5 presents the market-specific evidence from the same records.
- Does V5 produce the device history record?
- Yes — the eDHR assembles as the device is built, capturing component lots, process steps, inspections, non-conformances, labels and signatures in sequence.
- How are complaints and vigilance handled?
- Complaints are logged with device and lot identity, assessed for reportability with a recorded rationale and clock, trended into risk management, and escalated to CAPA where thresholds are met.
- Is V5 itself validated for device use?
- V5 supports computerised system validation with IQ/OQ on private-cloud deployments and a validation pack; see the validation page for the current independent assessment status.