01
Unified TechDoc and QMS
One system for technical documentation and QMS. Scalable, with no vendor lock-in.
Start with regulatory strategy: intended purpose, classification, and the standards that apply. Then guided setup of QMS and TechDoc on pre-configured EU MDR and FDA templates, with AI ready in the product so you are not writing everything by hand.
Guided product setup
Sterilizator 20A · MDR Class IIb
Applying MDR configuration
Configuring Sterilizator 20A…
Templates, SOPs, and risk-class links
Why teams start here
Limited internal regulatory expertise, a first CE certification ahead, and a need to move faster than hiring allows. Programmes on CertHub reach certification up to 60% faster, with up to 70% fewer repetitive tasks.
One system for technical documentation and QMS. Scalable, with no vendor lock-in.
Purpose-built templates for EU MDR and FDA, plus a guided product setup. Customers report up to 70–80% of content already preset, so you only adapt what is specific to your device.
Regulatory strategy consulting through our partner network, plus guided services embedded in the product, not bolted on after you buy.
Transparent subscription pricing with a clear and rapid ROI, so you can qualify yourself quickly.
From regulatory strategy to a submission-ready package. Pre-configured content plus AI in the product is why teams move significantly faster than building QMS and TechDoc from scratch.
Define intended purpose, device characteristics, risk classification, and applicable standards as structured design input.
That strategy becomes the spine for QMS, TechDoc, and later submissions, not a slide deck that dies in email.
A structured questionnaire provisions the data model for your product class: MD, IVD, or SaMD.
Platform access plus an onboarding and guidance program from day one, matched to how much CertHub should do with you.
Guided product setup
Sterilizator 20A · MDR Class IIb
Applying MDR configuration
Configuring Sterilizator 20A…
Templates, SOPs, and risk-class links
Establish the initial QMS: processes, roles, and regulatory requirements. Or have CertHub take over selected responsibilities.
AI is ready in-product to draft and adapt SOPs, forms, and lists from pre-configured content, so you spend time reviewing, not blank-page writing.
Complaint Handling
SOP · BPMN process
Each step links a form, template, or role — not a Word SOP.
Generate Annex II/III-style technical documentation from approved regulatory data and EU MDR or FDA templates.
AI assists on regulatory questions and document drafting against live product data. You stay in control of every approval.
Risk Management Plan
Sterilizator 20A
Document Information
Guided Services
This is the engagement path we run with first-certification teams. You choose how much CertHub does: guidance beside you, or selected work packages taken over, while approvals stay with your organisation.
01
We lock intended purpose, device characteristics, risk classification, and applicable standards first. That decision set drives everything that follows, instead of rebuilding strategy inside every document.
02
We establish the Quality Management System, configure regulatory and QMS processes, and stand up a structured product file as the single source of truth. Forms, lists, and templates connect to that file, not to orphaned Word copies.
03
Technical documentation is generated from the approved regulatory data model, using pre-configured packages for your device type. AI is available to draft and adapt content so your team reviews and decides, rather than typing every chapter.
04
We compile the finalisation path toward a Notified Body package from the same spine. After certification, that model stays the basis for maintaining TechDoc and QMS, not a one-off project dump.
Also relevant
Levels of collaboration on one side. The platform that carries the data model on the other.
Proof
Lower cost than building a regulatory team. Up to 60% faster to certification on CertHub. Also: Elixion (platform plus guidance), BugSense (75% faster certification readiness, €205K saved), and Urikon (IVDR QMS and TechDoc in 4 weeks).
Next step
See how strategy, guided QMS and TechDoc, and AI in the product would look for your first CE path.
