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.

Classify Your Device →

Start CER Drafting →

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

Ready to streamline your CER workflow?

Join medical writers who are already creating compliant CERs in half the time.

95%

Classification Accuracy

50+

Countries Covered

Why 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

Full CER drafting workflows (AI-assisted)

Template library (CER, PMS, PMCF, IFU, GSPR)

eQMS implementation guidance