From nanosensor evidence to regulatory confidence.
The quality and regulatory evidence backbone for NIVD — turning scientific work, SciSure records, design controls, risk and regulatory evidence into an audit-ready operating system.
Built for
One controlled system, from evidence to approval
Executive-friendly at dashboard level, evidence-deep beneath. Every controlled record carries status, owner, version, audit trail, signatures and related evidence.
Controlled records & e-signatures
Every SOP, protocol, design output and report is versioned, approved with e-signatures and backed by a full audit trail.
SciSure evidence links
Connect Barcelona R&D and SciSure ELN/LIMS records directly to the regulatory decisions they support.
Design controls & risk
Manage development plans, verification, validation and ISO 14971 risk against every product configuration.
Quality events
Track CAPAs, deviations, non-conformances, complaints and change control with owners, due dates and clear status.
Supplier & CDMO oversight
Qualify suppliers, CDMOs, CROs and partners, and govern the responsibilities that sit outside ProductCo.
Readiness reporting
See ISO 13485, IVDR, UK, FDA and UAE readiness at a glance — and know your gaps before auditors or partners find them.
Access is controlled
NIVD QMS is an internal, invite-only system. Sign in with your NIVD credentials, or request access from your quality and regulatory administrator.
NIVD QMS — confidential controlled system. Printed or exported copies are uncontrolled unless marked as a controlled PDF.