Placing a medical device or SaMD on the European market requires rigorous compliance and formal CE marking under EU MDR or IVDR. Glaze Medical guides your team efficiently through every milestone.
Step-by-Step CE Approval With Glaze Medical
1. Classification & Preclinical Evaluation: Determining risk class, applicable standards, safety testing, and verification plans.
2. Technical Documentation: Building a clear, traceable Technical File covering GSPR, Design Controls, and ISO 14971 risk management.
3. Clinical Evaluation (CER): Demonstrating clinical safety, performance, and positive benefit-risk profile.
4. QMS & Audit Readiness: Preparing your ISO 13485 QMS and team through internal audits and pre-submission reviews ahead of Notified Body assessment.
5. Post-Market Surveillance (PMS): Maintaining compliance after launch with systematic PMS and PMCF processes.
Contact Glaze Medical to make your journey to CE approval structured, predictable, and efficient.