Our Experience Matters
Andaman Medical is a global consulting firm with over 15 years of experience in medical device regulatory and clinical affairs for medical markets in Asia
With a global experience in medical devices regulatory, compliance and clinical affairs, Andaman Medical is your trusted partner across Southeast Asia. Strategically positioned throughout Southeast Asia – Singapore, Malaysia, Indonesia, Philippines, Thailand and Vietnam, we facilitate manufacturers from USA, Canada, Europe, ANZ, Japan, Korea, China to reach the ASEAN market and beyond, focusing on intricate regulatory differences between global regulations and diligently following local procedures and updates.
Why are we successful?
Andaman Medical is a full-service medical device consultancy company that provides a fully synchronized approach to all your quality, regulatory, and clinical requirements for Southeast Asia, US and EU medical device or IVD submissions. Our synchronized methodology, helps to save companies both time and money, while ensuring full compliance with regulatory requirements. In addition to streamlining your medical device or IVD submission process, we also provide expert training on all phases of product development and regulatory processes.
- Regulatory strategy
- Medical device and IVD product registration
- Authorized representation
- Quality management systems
- Establishment licensing
- Business support services
- Audits, training and support