FDA

FDA

U.S. Food and Drug Administration

ISO 13485:2016

ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

MDSAPMedical Device Single Audit Program

MDSAPMedical Device Single Audit Program

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements

BSI

BSI

BSI is a leading representative group for manufacturers in the life-science and educational/medical research industry.

About us

We pride ourselves on the ability to realize and produce in-house

To get a better idea of us and what we do, please watch our corporate video.

Successfully providing the best business solutions since 2017

SERVICES

Services we serve to all over the world

We pride ourselves with the ability to realize and produce in-house, with a number of services, which are valuable to our partners.

MORE ABOUT US

Kaiyan Medical

OUR PEOPLE

Behind great services, great people

Alain Dijkstra

CEO

Jason Cheng

Head of Engineering

Lisa Hong

Human Recources