The Venitara tool kit
Complete regulatory support
One file that keeps growing.
MDR, IVDR, SaMD, 510(k), DeNovo
How the eight fit together
01PathwayReady
02MarketReady
03CompanyReady
04EvidenceReady
05SubmissionReady
06RevenueReady
Your file, growing. Each stage begins with the work already in it.
Diligence Ready
Fully ReadyAttach at any point on the track.Your client room
Set up in minutes. Every stage of the work lives in it.
AI gets you started
Drafts your documents and finds the gaps, marked as unreviewed.
Experts validate
A senior expert checks the deliverables that carry consequences.
Start hereto define the regulatory roadmap and market entry plan
Venitara PreparationPathway Ready
Use this when you need to determine how your product is regulated and what must happen next.
You receive
The Regulatory Roadmap
Venitara Market AtlasMarket Ready
Use this when more than one market is in play and the order has not been decided.
You receive
The Market Sequence
Continue hereto build the QMS system and evidence plan
Venitara QMS FoundationCompany Ready
Use this when an audit comes into view, or development becomes formal and responsibilities start to spread.
You receive
The Operating QMS Foundation
Venitara Evidence EngineEvidence Ready
Use this when testing is under way but the link between regulatory requirements and available evidence is unclear.
You receive
The Evidence Map
Finish hereto prepare the submission and product launch
Venitara Certification Preparation SprintSubmission Ready
Use this when a submission date or Notified Body application is approaching.
You receive
The Submission-Ready Technical File
Venitara LaunchpadRevenue Ready
Use this when the pathway is settled and the commercial questions turn urgent.
You receive
The Reimbursement Dossier
Available at any stage
Venitara Investor ProofDiligence Ready
Use this when a funding round, term sheet or data room requires a documented view.
You receive
The Regulatory Due Diligence Pack
Venitara CompleteFully Ready
Choose Complete when you want the full pathway in one subscription.
You receive
The Living Technical File
The Venitara Attestation records that a named senior regulatory expert has reviewed this document against the Venitara rubric, confirming concordance with the applicable regulatory requirements and assessing it as ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
Choose how much expert support you need.
AI-generated from your answers, marked as unreviewed.
Included in membership
A senior expert reviews it and records what holds.
Fee per document
Assessed for submission readiness, with the outcome in writing.
Contact us for pricing
Add to any product
Three things you can attach to any product.
Fractional PRRC
A named person for the Article 15 role.
Appointed under written agreement and named in your file.
A standing expert
One senior expert who holds your file across every product.
For the questions that arrive between milestones.
Governance documentation
AI Act, data protection and product safety, built alongside the device file.
At the assurance level the product was produced at.
Not sure where to start?
The free MedTech Compass takes about ten minutes. It gives you an indicative view of how your product is likely to be regulated, what you already have, and what to do next.