A regulation is changing
A regulation is changing: see which of your documents are affected, the same day
When MDR, IVDR or an FDA rule changes, someone has to find every document the change touches: procedures, technical files, risk analyses, labelling. Done by hand, that sweep takes weeks. Nitro cOS maps the dependencies between your documents and the requirements behind them, so you see which documents are affected the same day the change lands.
What the regulation requires
Medical device regulation is not static. Recent years alone brought new MDR and IVDR transition timelines, the FDA's Quality Management System Regulation, a steady stream of MDCG guidance, revised harmonised standards and the EU AI Act for devices that use AI. Each change can alter what your documentation has to show.
Both MDR and ISO 13485 expect manufacturers to keep technical documentation and the quality management system current, and to assess the impact of regulatory changes through change control. Notified bodies and FDA inspectors ask for evidence that this assessment happened, not just that the documents were updated.
The difficulty is scale. A single change to a standard can affect dozens of documents across several products, and the links between them usually live in people's heads rather than in the QMS.
How Nitro helps
Nitro cOS holds a living map of how your documents depend on each other and on the requirements they satisfy. When a regulation, standard or guidance changes, Nitro flags which documents are affected and why, with a reference to the clause that changed.
Affected documents go to the right owner with a proposed change drafted from your existing material, so the update starts from the current approved version rather than from scratch. A named reviewer approves every change, and the full history is recorded.
The same map works in the other direction. When a product changes, Nitro shows which requirements and documents the change affects, which gives change control a complete picture before the decision is made.
Questions
- How quickly does Nitro show what a regulation change affects?
- The same day. Once the change is in Nitro, the dependency map shows the affected documents immediately, instead of after a manual review of the archive.
- Does Nitro update the documents automatically?
- No. Nitro proposes the change and drafts it from your existing documents. A named person reviews and approves every change before anything enters your quality system.
- Does this also cover product changes?
- Yes. The dependency map works in both directions, so a change to the product shows which requirements and documents are affected, as input to change control.