Detect
Picks up compliance-relevant changes in the tools engineers already use.
CADCT-1042 Rev C tip geometryDesign
ERPCO-291 wire supplierSupplier
Gitfirmware v1.4.2Software
Design control automation for medical devices
Compliance that enforces itself.
Omni Octa watches your CAD and PDM, Git and ERP for design changes, maps each one to the requirement it triggers, and blocks design freeze until every gap is closed. Every decision lands in a tamper-evident audit trail.
ISO 13485FDA QMSRIEC 62304ISO 14971EU MDR
For QA and RA teams. Prefer to explore first? Try the interactive demo
Compliance event detected14:32:01
CAD / PDM · revision released
CT-1042 catheter tip · Rev C
Tip angle changed from 15° to 22°
Requirement triggered
ISO 13485 §7.3.9 · Design change review
Gaps found (2)
Risk file not updated · V&V scope not reassessed
Owner asked for evidence
J. Mehta (QA) · due Friday 17:00
Design freeze v2.1 blocked · 2 items open
Built by medtech operators
Founded by the team that took a Class III spinal implant through FDA clearance and EU MDR certification.
Deterministic verdicts
Rules decide what is compliant, not a chatbot. The same event gives the same answer every time, with the clause to prove it.
Design partner program
We're working with a focused group of medtech teams building toward FDA clearance or EU MDR.
Platform
Your eQMS stores the record. Omni Octa makes sure it exists.
Six capabilities that close the gap between where engineering decisions happen and where auditors look for them.
Reason
Maps each event to the clause it triggers, across every framework you're held to.
EventCT-1042 Rev C released
RequirementISO 13485 §7.3.9
Rule match0.97
Follow up
Asks the right owner for the right evidence, then chases until it arrives.
To: j.mehta@yourco.com
Risk file update needed: CT-1042 Rev C
The tip angle change requires a risk file review before design freeze. Due Friday 17:00. Reminder queued for Thursday.
Enforce
Blocks design freeze, release or submission until every condition is met.
Design freeze v2.1 Blocked
Design review record
Risk file (ISO 14971)
V&V scope reassessed
Prove
Logs every decision with its reasoning, clause and a cryptographic hash.
event EVT-2026-0418
rule ISO_13485_7.3.9
by rule-engine + R. Okonkwo
hash a3f9b2c14d8e6f2a…
prev 7c3a1b9f2d4e8a6c…
rule ISO_13485_7.3.9
by rule-engine + R. Okonkwo
hash a3f9b2c14d8e6f2a…
prev 7c3a1b9f2d4e8a6c…
Keep the DHF current
Shows which parts of the Design History File drifted behind the product.
Steerable Catheter v2.1
Design inputsComplete
Risk fileOutdated
Traceability3 unlinked
How it works
One design change, start to finish.
An engineer releases a new revision in CAD. Without Omni Octa, the risk file update gets remembered weeks later, or found by an auditor. With it, the gap is caught in seconds and the freeze waits for the fix.
4 secfrom released revision to blocked freeze
See it on your own design data
- Engineer releases CT-1042 Rev C
Catheter tip angle changed from 15° to 22° in the CAD model.
source: pdm-webhook - Design change review triggered
A change to a released design output requires review, verification and risk assessment.
ISO 13485 §7.3.9 · FDA QMSR - Two gaps found in the DHF
The risk file wasn't updated and V&V scope wasn't reassessed for the 22° variant.
ISO 14971 · DHF scan - Owners asked for evidence
J. Mehta gets the risk file task, R. Okonkwo the V&V review. Both due Friday 17:00.
escalates to QA manager Thu 09:00 - Design freeze v2.1 blocked
Release can't proceed while two obligations are open.
enforcement gate: active - Gaps closed, freeze released
Evidence attached, reviewer signs off, and the decision is hashed into the audit trail.
record EVT-2026-0418 · signed
Regulations
Built on the standards your auditor reads.
Each event is checked against the clauses that actually apply, so one design change can trigger obligations in several frameworks at once.
ISO 13485:2016
Quality management
Design and development controls, design changes and purchasing.
§7.3§7.3.9§7.4
21 CFR Part 820FDA QMSR
In force since 2 February 2026, incorporating ISO 13485 by reference.
§820.10§820.35
IEC 62304Medical device software
Software change classification and maintenance releases.
§6.1§6.2§8
ISO 14971:2019Risk management
Risk file updates when the design or its use changes.
§7§10
EU 2017/745EU MDR
Technical documentation that stays current with the device.
Annex IIArt. 10
The missing layer
Systems of record don't execute anything.
Every tool in a medtech stack does something useful. None of them notice a compliance event and act on it.
| Tool | Detects events | Applies the clause | Blocks release | Audit-ready record |
|---|---|---|---|---|
| eQMSGreenlight Guru, Veeva | ||||
| Engineering toolsCAD, PDM, Jira | ||||
| AI copilotsGeneric LLM tools | ||||
| ConsultantsExpert review on demand | ||||
| Omni OctaCompliance execution |
YesPartly or manuallyNo
Who it's for
For QA and RA teams who can't afford to find out at audit time.
Keep a mature portfolio compliant as it keeps changing.
Every sustaining change, supplier swap and firmware patch is a compliance event.
- Design and supplier changes caught as they happen
- DHF and risk files that stay current
- Audit prep in days instead of weeks
Add products without adding QA headcount.
When change volume outgrows the team, manual coordination becomes the bottleneck.
- One rule set across every product
- Owners chased automatically
- Release gates that don't depend on memory
Walk into your 510(k) or CE review with a complete file.
Traceability built while you engineer, not reconstructed before the deadline.
- Traceability gaps flagged early
- Decisions recorded with their clause
- No last-minute DHF assembly
Why we built it
We took a Class III implant through FDA and EU MDR. The hardest part wasn't the science. It was keeping the paperwork in step with the engineering.
- Company
- Omni Octa B.V., founded June 2026 in Den Haag, the Netherlands
- Background
- Founders who built and certified a Class III spinal implant company
- Technology
- Language models read the documents; a rule engine makes the call. Patent pending.
- Serving
- Medical device teams building for the EU and US markets
See Omni Octa on one of your own design changes.
A 30-minute walkthrough with a founder. Bring a recent change; we'll show you what it should have triggered.
Or ask about the design partner program.
Prefer email? info@omniocta.com