Won-Med VINA CO., LTD.

Won-Med established based on quality management system certification body. With a global experience in medical devices regulatory, compliance and trading, Won-Med is trusted partner across Southeast Asia. Strategically positioned throughout Southeast Asia, we facilitate manufacturers from USA, Europe, Korea, Japan, and China to reach the ASEAN market and beyond, focusing on intricate regulatory differences between global regulations and diligently following local procedures and updates. Won-Med services for Medical Devices and Healthcare include: - Regulatory Intelligence - Product Registration & Establishment Licensing - Quality Management Systems (ISO 13485, US FDA 21 CFR part 820, GDPMD) - Business Services - Auditing, Training & Support Won-Med provides a complete range of services for all Quality and Regulatory needs for Vietnam submissions. Our methodology brings time and financial efficiency for compliance-related issues with regulatory requirements. In addition to stream-lining your submission process, we offer expert training in all phases of the development and regulatory process. We are always looking for bright, energetic people who would like to advance their career in the medical device regulatory industry.