The operating system for MedTech, from idea to post market.
One secure platform for product, development, quality, compliance and operations, always audit ready.
- ISO 13485
- FDA QMSR
- 21 CFR Part 11
- EU MDR
- ISO 27001 aligned
- GDPR and HIPAA aligned
User needs, requirements, controlled documents, CAPAs and training live in one audited system. Change one record and everything built on it is flagged for review.
Enter through any module, keep adding as you grow.
Each module works on its own. Add another and it links to the records you already have: a CAPA links to the change request it raised, and the change request to the training that followed.
OPRA Start
Requirements and traceability
Traceability that tells you what went stale.
Collect user needs and requirements for each product and keep them linked from user group to IFU.
- Changes flag downstreamEdit a user need and everything built on it is marked out of date.
ISO 13485 7.3.9 - Sources can’t vanishA need can’t be deleted while a requirement still uses it.
ISO 13485 4.2.5 - Present in minutesOpen the requirement matrix and walk a reviewer through the product.
ISO 13485 7.3.10
OPRA Docs
Document control
The simplest eQMS you will operate.
Write in OPRA Flow’s own editor or in your office suite. Every change runs through a change request: draft, review, approval, training and release, each waiting for the right people.
- Four eyes, enforcedAuthors can’t review or approve their own change.
ISO 13485 4.2.4 - Approval is fingerprintedSigning off freezes a SHA-256 snapshot of the whole package.
Part 11 §11.70 - Controlled copiesDownloads are watermarked and every one is logged. The released record keeps its redlines, old versions and review dates.
ISO 13485 4.2.5 - Role-based accessDecide who sees and signs what, across the whole platform.
Part 11 §11.10(d) - SpacesShare uncontrolled documents without falling back to a shared drive.
ISO 13485 4.2.4
OPRA Events
CAPA, NCs and deviations
Every quality event on screen, not on paper.
Raise CAPAs, nonconformances, security incidents and planned deviations, and link them to each other.
- Gated checkpointsEach stage waits for the reviews it needs.
ISO 13485 8.5.2 - Effectiveness checksReopen an event when the results say the fix didn’t hold.
ISO 13485 8.5.2, 8.5.3 - Reminders before deadlinesOwners hear before a deviation expires, extends, closes or escalates.
ISO 13485 8.3
OPRA Train
Training and competence
Training that keeps knowledge in the team.
Assign read-and-understood training when a document changes, run classroom sessions, and grade competency assessments. The matrix shows who is trained, who still owes it and who is overdue.
- Release waitsChoose whether training comes before or after release.
ISO 13485 6.2 - ProgramsBuild the curriculum each role needs.
ISO 13485 6.2 - CertificatesGenerate certificates that show competence and effectiveness.
ISO 13485 6.2
What we’re building next
Start, Docs, Events and Train.
Risk, Regs, Build, Plan, Supply, Control, Labs and Apps. to shape them.
- 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
“We are VERY impressed with the streamlined workflows within OPRA FLOW. It is much preferred over our previous eQMS.”
Ask across your whole QMS and get the answer in seconds.
OPRA AI reads Start, Docs, Events and Train with your permissions, drafts the records you ask for, and changes nothing until you confirm. It runs on latest-generation models, with inference kept in the EU.
Timed on our demo workspace
- “What’s waiting on my signature, and what does each change request change?”6 s
- “Summarise the open CAPAs, nonconformances and deviations with their owners and due dates.”8 s
- “Draft a user need for this product: the patch stays on through a shower.”8 s
Time to a full answer, or to the change card for the draft. Median of three runs, October 2026. Larger workspaces and longer questions take longer.
- Sees only what you can. Every lookup runs as you, with your role’s permissions.
- Drafts across the modules. User needs, URS, PRS, change requests, CAPAs, nonconformances and training programs.
- Reads your files. Drop in Word, Excel, PowerPoint or PDF and draft from them. Edits to a draft Word document arrive as tracked changes in your name.
- Never signs. It can’t review, approve or e-sign. Each change waits for your Confirm and lands in the audit trail.
Prefer your own assistant? Connect Claude, ChatGPT, Cursor or VS Code over MCP, with the same permissions.
“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.”
“An affordable, AI-supported QMS that grows with us. Exactly what an early-stage medtech company needs.”
Your data stays yours.Isolated, encrypted, exportable.
- Isolation
- Each customer’s data is isolated at the database level, on every query.
- Encryption
- Encrypted in storage and in transit, backed up, and never used to train AI models.
- Exit
- Export everything with one click, whenever you want.
- Testing
- OWASP Top 10 tested continuously. ISO 27001 certification in progress.
We take a real change request from first draft to release, across all four modules.
We moved 40 GB of eQMS data from Arena PLM in a few hours.