MDR Compliance Project

PROJECT OVERVIEW
CAI assisted a confidential medical device manufacturer in Tbilisi, Georgia, to achieve compliance with the new Medical Device Regulation (MDR). The project spanned approximately 1.5 years and involved a comprehensive overhaul of the client’s Quality Management System (QMS). CAI conducted an initial gap assessment, designed a project roadmap and led multiple workstreams to address identified gaps. The team updated all company processes, developed new procedures and templates and guided the client through the Notified Body application process. As a result, the client established a new quality culture, opened new markets and improved their products while achieving MDR compliance.
Topics covered
- MDR gap assessment and compliance strategy
- QMS adaptation and process improvement
- Development of MDR-compliant procedures and templates
- Technical file creation for product information
- Regulatory strategy revision and Notified Body application support
- Clinical studies, biocompatibility and sterilization validation updates
- Quality culture transformation in medical device manufacturing