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.
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.
🚀 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
95%
Classification Accuracy50+
Countries CoveredWhy 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.
Free
Free
Device classification (EU, US, UK)
Basic regulatory guidance
Market selection
CER sample outline
Premium
Premium
Full CER drafting workflows (AI-assisted)
Template library (CER, PMS, PMCF, IFU, GSPR)
eQMS implementation guidance