Compliance Made Simple From Classification to CER Creation
From accurate device classification to fully guided Clinical Evaluation Reports (CER), Qmedify delivers step-by-step regulatory workflows powered by AI and backed by real-world expertise.
See Qmedify in Action
From device profile to submission-ready documentation
A real look at the platform — AI-drafted CER sections, automated literature search, and a fully documented screening workflow.
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Comperhencive Guidance
Everything you need for medical device certification
Device Classification (AI-powered)
Determine EU/US/UK class and applicable regulations with 95% accuracy. Includes Annex VIII breakdown, justification, and exportable summary.
CER Drafting Support
Generate structured Clinical Evaluation Reports aligned with MDR Annex XIV, MEDDEV 2.7/1 Rev.4, and MDCG guidance. AI-assisted evidence extraction, literature structuring, and gap analysis for medical writers.
Quality Management (ISO 13485)
Step-by-step eQMS guidance and templates built for modern medical device teams.
Technical Documentation
Guided creation of essential MDR/IVDR documentation — GSPR, RMF, IFU, PMS/PMCF plans.
Literature Search & Screening
NEWOne click searches PubMed, Embase, and Semantic Scholar simultaneously. AI writes the query, two-level screening records every decision, and PRISMA diagrams generate automatically.
AI Regulatory Assistant
NEWAsk questions in the context of your specific device, document, and fetched literature — for regulatory Q&A, writing suggestions, and section reviews on every screen.
🚀 Built for Medical Writers
Create CERs faster without compromising compliance
Qmedify helps medical writers:
Structure CERs instantly based on device type
Identify literature gaps and regulatory risks early
Generate clean draft text aligned with MDR rules
Reduce review time through consistent, high-quality outputs
Manage multiple client devices in one dashboard
Export CER sections in DOCX or PDF format
One Platform, Every Document
Full document lifecycle, no more emailing Word files
Every CER, PMCF Plan, PMS Report, and SSCP moves through the same clear, audited workflow — from CER to PSUR to IFU and beyond.
1
Draft
AI generates each section from your device profile
2
In Review
Assign reviewers and track section-level feedback
3
Approved
Set approval dates and lock the document number
4
Issued
Export a submission-ready package, fully traceable
13+Ready-to-use document templates
100%Change history captured, who and when
EU · US · UK · CA · AUScope any document to its target region
95%
Classification Accuracy50+
Countries Covered13+
Document Templates3
Databases Searched At OnceWhy Now?
Regulatory Pressure Is Increasing
The regulatory landscape is evolving rapidly. Stay compliant with AI-powered CER solutions.
68%
of manufacturers report delays due to insufficient CERs (MedTech Europe 2024)
€1.2M
Average cost of CER-related delays per device
Ongoing
MDR requires ongoing clinical evidence — not a one-time document
Qmedify helps you navigate these challenges with AI-powered automation and expert regulatory guidance.
Unlock Premium Features
Get access to comprehensive regulatory guidance, QMS templates, and expert support.
Premium
Premium
Full CER drafting workflows (AI-assisted)
Template library (CER, PMS, PMCF, IFU, GSPR)
eQMS implementation guidance