The Operating System for Med Tech, from Idea to Post Market.

OPRA Flow is one secure platform connecting product, development, quality, compliance and operations, always audit ready and lean by design.

See how the modules connect
  • ISO 13485
  • FDA QMSR
  • 21 CFR Part 11
  • EU MDR
  • ISO 27001 Aligned
  • GDPR/HIPAA Aligned

Medical device teams already on OPRA Flow.

“We are VERY impressed with the streamlined workflows within OPRA FLOW. It is much preferred over our previous eQMS.”

Amy Bennett, InnotiveDX

“The support and system the OPRA FLOW team have provided has really helped to demystify the process, which can be overwhelming when building a medical device for the first time.”

Iwan Roberts, Pinnacle Neuroscience

“An affordable, AI-supported QMS that grows with us. Exactly what an early-stage medtech company needs.”

Øyvind Gulbrandsen, Neurolytix AS

OPRA Start

Traceability that tells you what went stale.

OPRA Start is a comprehensive requirements management tool built for MedTech to help collect and maintain requirements without needless rework.

  1. User groups
  2. User needs
  3. URS
  4. PRS
  5. Intended use
  6. IFU

  • Changes flag downstream

    Edit a user need and everything built on it is marked out of date.

    ISO 13485 7.3.9

  • Sources can’t vanish

    A need can’t be deleted while a requirement still uses it.

    ISO 13485 4.2.5

  • Present in minutes

    View your requirement matrix and present your product in minutes.

    ISO 13485 7.3.10

OPRA Docs

The simplest eQMS you would ever operate.

  • Four-eyes, enforced

    Authors can’t review or approve their own change.

    ISO 13485 4.2.4

  • RBAC Powered

    Control who sees what with a simple to implement Role based access control throughout the entire platform.

    Part 11 §11.10(d)

  • Live KPIs

    Use live KPIs for transparency and visibility.

    ISO 13485 8.4

  • Work online and offline

    Prevent data fragmentation with our in-platform collaboration using OPRA Flow’s own editor, or work with your office suite and move documents into OPRA Flow.

    ISO 13485 4.2.4

  • Spaces

    Escape from non validated shared drives and use our Spaces feature to share uncontrolled documents.

    ISO 13485 4.2.4

OPRA Events

All Quality Events, fully digital.

Raise CAPA, NCs, Security Incidents and Planned Deviations and weave between them without any paperwork.

  • Gated checkpoints

    Everything moves with appropriate reviews.

    ISO 13485 8.5.2

  • Track Effectivity

    Reopen events based on results and trends.

    ISO 13485 8.5.2, 8.5.3

  • Smart Notifications

    Get notified before deviations expire, extend, close or escalate.

    ISO 13485 8.3

OPRA Train

Prevent knowledge silos and have fun training.

With AI doing a lot, get your cognitive gym, fully compliant.

  • Release waits

    Release process either before or after training.

    ISO 13485 6.2

  • Training Programs

    Curate and deploy the best program for your company.

    ISO 13485 6.2

  • Certificates on demand

    Generate compliant certificates to prove competency and effectivity of training.

    ISO 13485 6.2

Streamlined records, everything audit trailed.

Understand the audit trail linkages. For example, a released document contains all compliant information in one place: what, who, why, when, periodic reviews, changes, redlines, old versions, downloads.

StartProductDocsChange controlEventsQuality eventsTrainTraining

Enter through any module, keep adding as you grow.

  • Start, live today: User needs, traceable requirements
  • Docs, live today: Document, change & training control
  • Events, live today: CAPA, NCs, deviations & incidents
  • Risk, building next: Device, business & security risk
  • Regs, building next: Complete regulatory submission management
  • Build, building next: ERP for MedTech manufacturing
  • Plan, building next: Idea to post market, including design control
  • Supply, building next: Supplier management
  • Control, building next: Production planning & quality engineering
  • Labs, building next: Calibration & equipment control
  • Apps, building next: Claims, complaints & more, expandable
  • Train, live today: Gamified training & competency

Live today

OPRA Start, Docs, Events and Train.

Coming next

Risk, Regs, Build, Plan, Supply, Control, Labs and Apps. Join the design partner list to shape them.

OPRA AI (Beta)

Use the power of AI within the OPRA Flow platform, fully private and secure.

The OPRA AI panel listing the products in OPRA Start, with each product's ID, version and status

Connect with MCP to accelerate your work.

Your data stays yours, encrypted and secure.

  • Each customer’s data is isolated at the database level, on every query.
  • Take out your data anytime with a click.
  • Your data is encrypted in storage and transit with industry standards, backed up, and never used to train AI models.
  • Every sign-off is fingerprinted: approval freezes a SHA-256 snapshot of the whole package.
  • ISO 27001 certification in progress.
  • OWASP Top 10 tested, continuously.

Migrate from your existing provider to OPRA FLOW within hours (*)

(*) Internal time taken to move 40GB of eQMS data from Arena PLM to OPRA Flow.

Request our security pack

See the whole system in one walkthrough.

We’ll take a real change request from first draft to release, across all four live modules.

Or email contactus@opraflow.com

Work on the go from your mobile, operational excellence in your pocket.

OPRA Start dashboard on a phone: products, user needs, coverage and open flags