Get Started
Solutions for Medical Device Regulatory Affairs Teams

RA without chaos, blind spots, or last-minute scrambles.

With Regtech, Regulatory Affairs (RA) teams don’t just manage submissions, they orchestrate market access. From structured dossier assembly to renewal tracking and integrated change control, your RA function becomes proactive, traceable, and inspection-ready at all times.

Centralized Submission Workspace

Regtech consolidates all regulatory activities in one place — submissions, correspondence, approvals, and commitments:

  • A single source of data for 510(k), CE/MDR/IVDR files, and international registrations
  • Live status for each product/market with clear due dates
  • Full traceability across QMS documents, decisions, and owners
Ensures controlled, traceable regulatory submissions with complete document integrity

Renewals & License Lifecycle — Always On Time

Regtech tracks expirations, renewals, and regulatory commitments with proactive reminders:

  • Calendar of renewals, surveillance audits, and regulatory fees
  • Escalations for overdue tasks and pending actions
  • Site-/market-wise views for portfolio planning
Prevents missed renewals and ensures continuous market authorization

Integrated Change Control & Impact Mapping

Every change is linked to its regulatory impact so nothing is missed:

  • Tie design/process/labeling changes to affected submissions and markets
  • Auto-notify RA when upstream changes are initiated
  • Maintain a documented rationale and decision trail
Demonstrates systematic regulatory impact evaluation for all changes

Labeling, UDI & Master Data Governance

Maintain compliant, synchronized labeling and identifiers:

  • Centralized IFUs, artwork, symbols, and language packs
  • UDI attributes and device data linked to products/markets
  • Change history and approvals logged end-to-end
Ensures labeling and device identifiers remain accurate, approved, and compliant across markets

Connected with Production/QA/PMS — In Real Time

RA doesn’t operate in isolation. Regtech ensures:

  • Deviations/CAPAs and risk updates flow into regulatory assessments
  • Design/R&D updates trigger RA review automatically
  • PMS trends inform variations, renewals, and risk files
Keeps regulatory decisions aligned with quality, risk, and post-market intelligence

Audit & Inspection-Ready — Every Day

Be ready for authorities anytime.

  • Instant retrieval of submissions, approvals, communications, and commitments
  • Complete audit trails of who changed what and when
  • Rapid evidence collation for notified bodies and regulators
Supports confident, stress-free regulatory inspections and audits

Centralized Regulatory Records

All approvals, dossiers, commitments, and letters:

  • Stored securely in one platform
  • Easily searchable with complete traceability
  • Role-based access control for RA leads, collaborators and auditors
Be ready for any inspection, even the surprise ones.

From concept to approval — Regtech connects the dots for timely, traceable market access.