Built for scrutiny. Strict by default.
Designed to support the requirements for traceability, version history and controlled access to electronic records.
Nitro Compliance acts as data processor. A data processing agreement is included and reviewed with your DPO or IT lead.
Nitro supports your existing quality management system under ISO 13485. It does not replace your QMS or change your processes.
Your documents, specs and policies are never used to train models. Ours or anyone else's.
Servers within the EU. Your data never leaves the EU, not even for backups. Encrypted at rest and in transit, with roles and a complete access log.
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.