Confideck handles the creation, maintenance, and international registration of technical documentation.
A secure, validated environment purpose-built for documenting and controlling regulatory information. Role-based access control, full document and content lifecycle management, and audit-ready traceability are built into the platform — not added as features.
Designed to support MDR, IVDR, FDA 21 CFR Part 11, and global regulatory requirements from the ground up — not adapted to them after the fact.
Regulatory content is managed at the database level — not the document level. Every entry, cross-reference, and content element is linked to a single source of truth. When data changes, all dependent documents update automatically across the entire technical file.
500+ redundant entries automated per technical file. Not by searching for text — by traversing structured content relationships in seconds.
AI specialized for technical documentation — not general-purpose. It understands semantic relationships across hundreds of documents, detects content gaps and inconsistencies, and supports change impact analysis. Specialized modules extend the platform for multi-market registration, submission preparation, and global compliance workflows. Every AI-assisted action is traceable, governed, and subject to human sign-off.
Customer data is never used to train models. The AI operates within the validated environment — controlled by design, not by restriction.
How Confideck is built
Each layer depends on the one below — the AI is only as good as the data model beneath it.
How Confideck is built
A secure, validated environment purpose-built for documenting and controlling regulatory information. Role-based access control, full document and content lifecycle management, and audit-ready traceability are built into the platform — not added as features.
Designed to support MDR, IVDR, FDA 21 CFR Part 11, and global regulatory requirements from the ground up — not adapted to them after the fact.
Regulatory content is managed at the database level — not the document level. Every entry, cross-reference, and content element is linked to a single source of truth. When data changes, all dependent documents update automatically across the entire technical file.
500+ redundant entries automated per technical file. Not by searching for text — by traversing structured content relationships in seconds.
AI specialized for technical documentation — not general-purpose. It understands semantic relationships across hundreds of documents, detects content gaps and inconsistencies, and supports change impact analysis. Specialized modules extend the platform for multi-market registration, submission preparation, and global compliance workflows. Every AI-assisted action is traceable, governed, and subject to human sign-off.
Customer data is never used to train models. The AI operates within the validated environment — controlled by design, not by restriction.
Live platform — ENT2233 Cardionyx
The Cardionyx system is a Class IIa active device intended for continuous non-invasive cardiovascular monitoring in clinical settings requiring real-time cardiac surveillance.
adult patients (≥18 years)adult and pediatric patients (≥12 years) requiring continuous cardiovascular monitoring. Pediatric use below 12 years requires supplementary clinical evidence per MDR Art. 61.6.
Class IIa per MDR Annex VIII, Rule 10. Basic UDI-DI: ++E23453123456. Risk class confirmed by notified body BSI 2025.
Use cases
The problem isn't managing documents. It's managing information consistently across hundreds of documents—and providing a secure, validated infrastructure for users' automation efforts. AI is used by everyone. Now we can support it within an infrastructure that was designed for the industry.
Talk to our initiators
We work directly with manufacturers — bringing real workflows, real documents, and real compliance environments into the development process. You don't just use the infrastructure. You help shape it.
A 30-minute call with our initiators — directly. No sales process. We talk through your regulatory environment, where documentation is slowing you down, and whether Confideck makes sense for your organisation.
Start the conversationNo commitment required. Just a conversation between people who care about the same problem.
