Value of a Medical Device ultimately hinges on a profound understanding of its application by a specific user to solve a specific clinical problem.
It is MD squared's belief that this understanding is at the core of providing a meaningful tool to the clinical practitioner, and in communicating why and how it makes a difference in his daily practice.
MD squared provides
- Clinical Evaluation & Validation Support
- Medical Support in Regulatory Strategy & Compliance
- Communication with Notified Bodies and Competent Authorities
- User Needs Assessment and Product Portfolio Analysis for clinical and economic value creation
- Clinical Risk-Benefit Analysis and Post-Market Surveillance Planning for Medical Devices
- Adverse-Event-Analysis, Mitigation, Reporting and Follow-Up