Guidance
Know what's required, from the start
The engineer describes what they're working on and gets the list of documentation required, with references to the regulation. Before the work starts, not after the audit.
How you work with Nitro.
Drafts
Drafts from your own documents
Nitro drafts from your earlier documents, product specs and policies. Not generic text, but your terminology and your product.
Reads from
QMS01
SharePoint02
Word03
Excel04
PDF05
More06
Dependencies
See the domino effect immediately
When MDR or FDA is updated, Nitro maps which of your documents are affected and flags them. No manual sweep of the whole archive.
What Nitro does.
Guidance
Requirements per task
The right requirements, before the work starts.
- Requirements list for what the engineer is building
- References to MDR, IVDR or FDA
- Gaps in existing documentation
- Prioritisation ahead of an audit
- One shared view for engineering and QA
Start here
Drafts
With your context
Written from your documents, not from scratch.
- Drafts from earlier documents and specs
- Follows your templates and policies
- Your terminology and product structure
- Citations back to the source material
- Export to Word
Dependencies
The domino effect
See what's affected when something changes.
- Map of dependencies between documents
- Flags impact of regulatory changes
- Flags impact of product changes
- Traceability and version history
- Input for change control
US presence
FDA requirements and MDR in the same dependency map, so one document can satisfy both without duplicate work.
Your existing QMS
Nitro reads your structure, your templates and your history. No system change, no moving documents.
Running without switching systems.
Connect Nitro to your QMS and SharePoint. Nitro reads documents, specs and policies, and engineers get requirements and drafts where they already work.
We set up the connection together with your QA lead. Think days, not a project.
Four steps
01
Connect your systems
QMS, SharePoint, document templates.
02
Nitro reads in
Documents, specs, policies.
03
The engineer gets the requirements
For what they're building right now.
04
Drafts and dependencies
Ready for QA review.
Find the requirements before the audit does.
An operating system on top of what you already have. The right documentation from the start, drafts with your context, and a map of what's affected when something changes.