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Families and variants share one model
Intended purpose, risk, evidence, and process data live once. Variants and related products pull from the same governed facts instead of parallel document trees.
Product families, variants, and new markets share one regulatory data model. Once the first jurisdiction sits on CertHub, the next ones are new templates on the same approved data, not another rebuild.
Product database
Sterilizator 20A · MDR
Knowledge Units
Device Description
Risk Management
Clinical Evaluation
Knowledge Topic
Intended Use
Why this page
For SME and mid-market RA and QM leads with one or more approved products and a footprint that is starting to branch.
Intended purpose, risk, evidence, and process data live once. Variants and related products pull from the same governed facts instead of parallel document trees.
We ship templates for EU MDR and FDA. Other jurisdictions stand up from the same model. New market access is mostly template work on data you already maintain.
Portfolio growth should not mean linear headcount growth. Structured data and generated submissions keep RA and QM capacity on judgment, not re-formatting.
Ten core domains stay on. Switch MDR, IVDR, or SaMD and the outer packages follow. FDA 510(k) sits in the model next to EU templates.
Always on
10 core domains
Added for MDR
We ship templates for EU MDR and FDA. The same model is how you stand up other jurisdictions.
The operating pattern once product data sits in one place.
Change: supplier for H₂O₂ cassette
Linked sterilization and risk records need updates before release.
Analyzing traces…
Links between objects show what a change touches across variants and filings.
Assess impact before you update documentation in five places by hand.
Change: supplier for H₂O₂ cassette
Linked sterilization and risk records need updates before release.
Analyzing traces…
Existing files and established templates move into the model.
You do not rebuild the portfolio from a blank page.
Drop .docx to import
Global submissions are generated from standardized templates on the same data model.
Another market is another template set, not another copy of every fact.
Submission Management
Regulatory Jurisdictions Worldwide
Digitally submitted to your Notified Body
EU MDR dossier sent. They will come back with the assessment.
EU MDR
European Commission · 2017/745
Submissions
Available
See Details →
Templates
Available
See Details →
Proof
One connected model across products and markets so audit readiness scales with the portfolio, not against it.
Go deeper
Same story, more detail. Not a ladder of products to buy next.
Next step
Walk through how your families, variants, and next market would sit on one data model.