Regulatory Strategy

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.