For MedTech manufacturers who want to build their own medical device technical file.
Over 100 templates for a complete medical device file with regulatory requirements built in.
Vetted LLM prompts designed to help you create each file and cover each requirement yourself.
One-time purchase and never a subscription. No need to rely on external software or a new tool.
Whether you target Europe, the US, or both, you need a complete technical file aligned to EU MDR / IVDR, or FDA requirements.
No CE or FDA, no distribution agreement. Distributors will not represent products without it.
Cross-border expansion is a regulatory question just as it's a sales one. But the dossier always comes first.
Investors and agencies price MedTech valuations against regulatory milestones. Post-CE rounds close faster.
Public funding programs and European national funding agencies treat CE as a milestone, not a goal.
Until the technical file is complete and compliant, every market, funding round and distribution deal are conditional.
Headers, footers, revision history, signature pages — all pre-built, consistent.
Numbered chapters aligned with MDR, IVDR, FDA and applicable ISO/IEC norms.
What goes where, why, and what authorities expect, written into each section.
Per-section prompts engineered to ground in your verified product data.
Drawn from real submissions. Shows what "good" looks like for each section.
How to use TechFile with AI safely. Plus one regulatory lead, included.
Each section of the dossier integrates the applicable regulatory guidance, recognized standards, and submission best practices — built in, not researched from scratch.
Choose the model that matches your device class and regulatory pathway. Each is built from the same logic — adapted for the specific dossier.
Active medical devices including those with electrical, electronic, mechanical, or energy-driven functions.
Sterile and non-sterile devices, implants, instruments, accessories, and procedure-related devices.
Software intended to be used for medical purposes, standalone or part of a connected device.
Technical documentation under EU IVDR for in-vitro diagnostics across all risk classes.
Every MDR, IVDR, and FDA dossier we have built for clients since 2017 has used a version of this framework. Refined across 100+ CE-marked devices. We are releasing it as a product because AI finally makes it a tool, and not a service.
We start developing and using our own framework for every dossier submitted in the EU. The foundation TechFile is built on.
Every recertification, every new product, every class, every dossier type. The framework hardens with each one.
The AI is finally good enough to make the framework a product, not a service. The first manufacturers get founding access.
A small selection of MedTech manufacturers whose documentation has been built with our system.
