01
Product data, not documents
Intended purpose, risks, and evidence live as structured objects, not paragraphs locked in a Word file.
Submission-ready files generated from approved product data and approved templates, versioned and change-controlled as your product evolves.
Risk Management Plan
Sterilizator 20A
Document Information
The job
Approved product data plus approved templates become the file, and stay current as the product evolves.
Intended purpose, risks, and evidence live as structured objects, not paragraphs locked in a Word file.
Templates pull live references so the file reflects approved data the moment you generate it.
Versioning and change control keep every filing current when the product moves.
Product data flows into templates and TechDoc. When something changes, CertHub flags what is outdated, AI maps the impact, and documentation refreshes across jurisdictions.
Source
LinkedProduct Data
General Information
Product Name
Sterilizator 20A
Basic UDI-DI
++E8C4123456789
Risk Class
IIb
Regulatory Status
Active
Device Description
Intended Use
H₂O₂ · reusable surgical instruments
Product Lifetime
10 years
Age Group
Via instruments
Demographic Focus
Hospital
Mapped
LinkedTemplate Collections
Output
LinkedTechnical Documentation
Product Name
Sterilizator 20A
Basic UDI-DI
++E8C4123456789
Risk Class
IIb
Intended Use
H₂O₂ · reusable surgical instruments
Live links across product data, templates, and TechDoc
In the product
Guided setup, families, custom fields, live templates, and versioning: the TechDoc jobs RA and QM leads use every week.
01 Capability
We tailor the data model to how you actually work and to this medical device: MDR or IVDR, class, and the structure the product needs. Not a blank database.
Guided product setup
Sterilizator 20A · MDR Class IIb
Applying MDR configuration
Configuring Sterilizator 20A…
Templates, SOPs, and risk-class links
02 Capability
Family data is inherited by child products. Change it once, the variants follow.
Product database
Sterilizator 20A · MDR
Knowledge Units
Device Description
Risk Management
Clinical Evaluation
Knowledge Topic
Intended Use
Maintained once. Every document references this record.
03 Capability
Schema libraries let you add or extend Knowledge Units and Knowledge Topics so the model matches your files, not the other way around.
Tracer
How Sterilizator 20A is connected
Sterilizator 20A
Product
Intended Use
KU
Risk Plan
Document
Design Control
SOP
GSPR Checklist
Template
EU MDR file
Submission
04 Capability
The file is generated from approved objects, not copy-paste from Word.
Risk Management Plan
TemplatePreview context: Sterilizator 20A
Same template. Switch the product — the references resolve to that record.
05 Capability
Draft versus approved. Reason for change. History you can show in an audit.
Complaint Handling
Locked for approval · v1.4
Electronic signature
Final Reviewer · 21 CFR Part 11 meaning
Also on this platform
Technical documentation sits on the same structured model as QMS and global submissions.
Proof
Startups and manufacturers generate submission-ready TechDoc from a structured model, not from parallel Word files.
Next step
We will show how approved product data and templates become a submission-ready file, and stay current when the product moves.