Developing a regulatory strategy for your medical device is key to market. At Yeng & Leong MedTech Consultancy, we work closely with your management and product development team to achieve this. The regulatory strategy includes key information such as:
- Medical device intended use and its technology,
- Target markets for commercialisation,
- Medical device classification,
- Regulatory requirements and
- Overall project milestones and timeline.
This document defines the go-to-market strategy for your medical device.