Launch FirstinMedtech
The AI platform that turns your design decisionsinto your regulatory submission — in real time.
Your team engineers. Your documentation keeps pace.
Risk management, V&V and traceability — complete, current, submission-ready.
Every regulatory pathway — FDA, EU MDR, EU IVDR.
The opportunity
Great engineering deserves
documentation that keeps pace.
Medical device development is rigorous by design. Design controls, risk management, traceability — this is what makes devices safe and submissions credible. The opportunity is to execute that methodology at the speed of modern engineering. That's what MANKAIND is built for.
Your regulatory record builds with every engineering decision — not before submission.
Every design change cascades through risk, requirements, and verification automatically.
Your engineers drive every decision. MANKAIND documents every output.
Rigour and velocity are no longer a trade-off.
Engineer your device. The documentation follows.
Assistant
Your Senior Colleague for Medical Device Engineering
Consult MANKAIND like the senior engineering colleague everyone wishes they had—deeply knowledgeable across design strategy, risk analysis, and regulatory context. Guidance on engineering decisions that shapes better products, available whenever you need it.
Workspace
Your Decisions, Automatically on Record
Design decisions flow into compliant documentation in real time. Full lifecycle traceability from user needs to verification—built into every design output, not written separately.
Vault
Your Quality System, Built Into the Design
Complete electronic quality management: CAPAs, NCRs, complaints, and audits with full traceability across your entire design history. Quality events connected to the engineering decisions that caused them.
Workflows
Rigorous Methodology, Zero Overhead
Multi-model AI agents handle the engineering cascade—a design change triggers risk updates, traceability revisions, and documentation generation. Submission-ready output for FDA and EU MDR, produced from your engineering decisions.
From design decision to regulatory submission
Design History File generation
MANKAIND compiles requirements, design outputs, verification records, and risk management files into a complete DHF package with bi-directional traceability. Draft DHF generated in hours, structured to FDA 21 CFR 820.30 and ready for expert review.
Design change impact analysis
When you change a component, MANKAIND traces the impact across electrical, software, and mechanical systems. It evaluates ISO 14971 risk profile changes and flags affected requirements for team review—in minutes, not weeks.
Requirements traceability matrix validation
MANKAIND validates bi-directional traces across your entire workspace—detecting orphaned requirements, untested features, and traceability gaps. Continuous monitoring ensures your matrix is audit-ready for FDA inspection per 21 CFR 820.30(j).
IEC 62304 software verification and validation
Generate IEC 62304 Class A, B, and C V&V documentation including unit test specifications, integration test protocols, system test plans, and SOUP analysis. Full traceability from software requirements to verification records.