Medical Devices and Biomaterial Plant Joint Stock Company (MEDEP JSC) is a high-tech medical devices manufacturer with technology transferred from the USA and Europe and facilities.
Our 10,000m2 factory in Ho Chi Minh city, Vietnam – within the Saigon High-tech Park – features an ISO 14644 (Class 7, 8, 9) Clean room; ASTM D1193 Reagent water system; ISO 11135 EO Sterilization system; ISO17665 Moist heat Sterilization system and fully equipped manufacturing, research and laboratory facilities.
MEDEP is more than just a manufacturer. We collaborate with domestic leading universities and research institutes, and as a research partner we work alongside some of the biggest names in the medical devices and biomedical industries.
Our Vision and Mission
Our Mission is to achieve the reputation of a quality, high standard implant medical devices in the Medical Equipment Manufacturing industry. We are committed to becoming a world-class company that meets and exceeds the expectations of our stakeholders.
Our Vision is to meet our customer expectations by delivering quality products at an affordable cost. Our forward vision is to strive to become a leading pioneer in Nano-technology based manufacturer in Vietnam. We also believe that for our scope of improvisation and we are always ready to take our achievements to the next level. We are growing and would always like to remain on the growing streak.
Our keys for development:
• Desire for Excellence
• Trust and confidence build-up
We believe in:
• Collective responsibility and leadership
• Professionalism and ethics
• Adding values to our client needs
MEDEP is committed to designing, developing and distributing implant medical devices that meet our customer expectations and comply with applicable regulatory requirements by maintaining the effectiveness of a quality management system.
Our quality management system (QMS) follows:
• EN ISO13485:2016 – Medical Devices, QMS. Requirements for regulatory purposes.
• EU Medical Device Directive 93/42/EEC.
• EU Medical Device Regulation 2017/745.
• ASEAN Medical Device Directive.
• Vietnam Decree 36/2016/ND-CP on Medical Devices.