EU IVDR software with performance evaluation live — PMS, PMPF, UDI-DI, and Annex II/III evidence in one place.
In vitro diagnostic manufacturers under Regulation (EU) 2017/746. Class A/B/C/D technical documentation aligned to Annex II and III, performance evaluation with scientific validity + analytical performance + clinical performance, PMS and PMPF plans, and EUDAMED-ready UDI-DI — all on an ISO 13485 QMS spine, not stitched around a legacy IVDD system.
You're shopping because the IVDD-era system can't carry a Class C or D file through NB review.
Technical documentation lives across Word, SharePoint and a legacy DMS
Performance evaluation report (PER) drifts from underlying studies within one release
PMS plan and PMPF reports are annual spreadsheets, not a live loop
UDI-DI records aren't structured for EUDAMED submission
Class up-classification (IVDD → IVDR) has doubled the evidence bar and nothing moved
Notified Body findings on 'traceability of evidence' repeat every review
IVDR, run as one live technical file.
Annex II & III technical documentation
One structured file per device covering Annex II (technical documentation) and Annex III (PMS) — every section linked to live evidence, no orphan PDFs.
Performance evaluation live
Scientific validity, analytical performance and clinical performance studies feed the PER as a live composite — not a re-typed annual document.
PMS + PMPF as a loop
PMS plan, PSUR/PMS report (per class), and Post-Market Performance Follow-up run as one loop feeding back into risk management and the PER.
UDI-DI structured for EUDAMED
UDI-DI, Basic UDI-DI, and device attributes structured to EUDAMED data model. Submission-ready without a data-mapping project.
ISO 13485 QMS spine
Design controls, DHF, risk (ISO 14971), CAPA and supplier controls — the QMS underneath the IVDR technical file, not two systems.
Class A/B/C/D differentiation
Evidence depth, NB involvement, PMS reporting cadence and PSUR obligations differ by class — the system enforces the right shape per device.
What changes the day this goes live.
- Technical file survives NB review without a 200-hour rebuild
- PER is composed from studies, not re-typed
- PMS/PMPF feeds risk and PER on a live loop
- UDI-DI submission to EUDAMED is a data export, not a project
- Class C/D devices carry the evidence bar they now require
The frameworks an IVD QA/RA lead owns.
Regulation (EU) 2017/746 (IVDR)
Full Annex I general safety and performance requirements, Annex II technical documentation, Annex III PMS, Annex XIII performance evaluation, and risk classification (A/B/C/D) modelled.
ISO 13485:2016
Design controls, DHF/DMR, risk hooks (14971), CAPA, supplier controls — the QMS spine every IVDR technical file lives on.
ISO 14971:2019 + ISO 20916
Risk management for medical devices and clinical performance studies for IVDs — evidence attached at the risk item and the performance study, cross-linked.
ISO 9001:2015
Document control (7.5), competence (7.2), nonconformity & CAPA (10.2), internal audit (9.2), management review (9.3) — all modeled, all evidenced.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
FDA QMSR (2026)
Aligned with the harmonized QSR/ISO 13485 final rule effective Feb 2026. Your QMS doesn't have to be re-architected — V5 is already there.
EU IVDR software, answered.
Does V5 support the class-based obligations (A/B/C/D)?
Yes. Evidence depth, notified-body involvement, PMS reporting cadence (PMS report vs PSUR) and PMPF obligations differ by class — the system enforces the right shape per device rather than treating every product the same.
How does V5 handle performance evaluation?
Scientific validity, analytical performance and clinical performance studies feed the Performance Evaluation Report as a live composite. The PER is not a document that drifts — it's a rendered view of underlying evidence.
Is UDI-DI ready for EUDAMED?
Yes. UDI-DI, Basic UDI-DI and device attributes are structured to the EUDAMED data model, so submission is a data export rather than a mapping project.
Can we migrate from an IVDD-era system?
Yes. Structured migration lifts existing technical files, risk assessments and post-market data into the IVDR data model and flags where the class up-classification creates evidence gaps that need study work.
Carry Class C and D IVDs through Notified Body review.
Free trial. Real technical file, real PER, real PMS loop.