Industries · Medical technology
Engineering that passes every audit.
In medical technology a compliance gap is more than a business risk, it can be a risk to patients. We help manufacturers run their engineering under ISO 13485 and the MDR so that evidence is produced in daily work, not just before the audit.
The particular situation
Catch up before the audit, then let it slide again.
Many mid-sized manufacturers hold their ISO 13485 certification but manage it reactively. They catch up before the audit, engineering carries on between audits, and the documentation lags behind.
At the same time, development is spread across sites, time zones and cultures. Then it is not enough for each site to work cleanly on its own. Roles, metrics and interfaces have to fit together across all of them, otherwise that is exactly where the gaps appear that an auditor will find.
How we help
Governance and evidence in one piece.
Governance across sites
Learn moreOne governance model with roles, metrics and interfaces that runs audit-ready under ISO 13485.
Continuous compliance, not last-minute
Learn moreComplAInow checks work products continuously against ISO 13485, the MDR and FDA requirements and shows gaps as soon as they arise.
AI without data leaving the building
Learn moreRegulated quality data stays in-house: every FORGE tool can run entirely within your own infrastructure.
Technical due diligence
Learn moreFor investors and buyers: how solid a manufacturer's engineering, documentation and regulatory readiness really are.
From practice
One governance model for two continents.
Medical technology, 2024
Engineering in Germany and Japan, one model
A medical technology group with strong products but engineering split between Germany and Japan, inconsistent processes and innovation that was too slow. We designed one governance model with roles, metrics and interfaces so the sites work consistently and audit-ready under ISO 13485, and integrated a development centre in India.
Result: development costs down 20 percent, more than 300 people aligned on shared metrics, faster decisions across sites.
When was your last audit without a scramble?
In the intro call we look at where your engineering and your evidence stand and what a ComplAInow pilot could look like for you.