For manufacturers
Build technical documentation centrally. Align it to every market you enter.
A server-hosted workspace where manufacturer teams analyze source material, organize evidence, and align technical documentation to the requirements of each target market. AI assists the work; your experts remain accountable for every release.
Market access waits on documentation that rarely travels cleanly.
Requirements differ by jurisdiction. Evidence and structure often do not. Teams rebuild similar documentation for each market, losing time that should go to product quality and clear evidence substantiation.
- 01
Reconstructing technical documentation for each target market instead of adapting a durable structure
- 02
Mapping claims and evidence to shifting requirement sets without a shared working environment
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Coordinating RA, clinical, and quality inputs across fragmented drafts and versions
From source packs to a release-ready TD dossier.
Bring clinical, risk, and design inputs into one controlled workspace. Structure them against market requirements, draft with inspectable AI assistance, and keep a human sign-off before anything is released.
Market-aligned structure
Organize technical documentation so one evidence base can be adapted to different requirement sets, instead of rebuilding the dossier for each jurisdiction.
Inspectable AI assistance
Use AI to analyze sources and help compile drafts your team can review, revise, or reject. Assistance never replaces a qualified release decision.
Human-accountable release
Keep a clear accountability boundary at the end of the workflow: people sign off. Software does not release documentation on its own.
Complements the assessment side we build with TDVeriX Med: preparation and review as two sides of the same conformity gap.
Clear about the edges.
Early conversations stay precise. We state what ToCGeniX Med is designed to support, and what it will not claim.
- Not an autonomous CE-marking or certification engine
- Not a substitute for your quality system, regulatory judgment, or notified-body assessment
- Capabilities and target markets continue to mature with stakeholder input
Help shape ToCGeniX Med with us.
Share markets, documentation pain points, and what would make this workspace useful in practice. We read every note.