Technical Documentation
Our technical documentation services ensure that all required information for regulatory submission is comprehensive, accurate, and compliant with the MDR. This is essential for achieving market access and maintaining regulatory approval.
- Preparation of technical documentation
We prepare detailed technical files, including device descriptions, risk analyses, and testing results, to support regulatory submissions. This documentation ensures compliance with regulatory requirements.
- Implementation of a Quality Management System
We assist in implementing a robust Quality Management System (QMS), to ensure your medical device meets international standards. Our service helps establish robust processes for maintaining product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.
- Compilation of the Clinical Evaluation Report
Our team compiles comprehensive Clinical Evaluation Reports (CER) that provide critical analysis of clinical data, demonstrating the safety and performance of the device in accordance with regulatory guidelines.