A Guide to Secure and Sustainable Market Authorization
The EU Medical Device Regulation (MDR) presents manufacturers with complex requirements: It demands extensive evidence of the safety, performance, and quality of medical devices. Our customized solutions help companies fully comply with MDR requirements:
- Regulatory consulting: Analysis of MDR requirements and development of customized implementation strategies.
- Quality management: Establishment and optimization of a quality management system that integrates all relevant MDR requirements.
- Clinical evaluation: Support in preparing clinical evaluations and evidence of product safety and performance.
- Post-market surveillance: Implementation of monitoring systems that ensure continuous safety and compliance.
With our experience in medical technology, we help companies ensure MDR compliance – for a smooth, internationally recognized market entry and sustainable business success.