QMS and Regulatory

Medical device companies are critical for the healthcare industry: They provide innovative solutions that improve patient  lives. Therefore we constantly seek to innovate, either by updating our existing technologies or by developing new technologies that are more effective by upholding our principles of quality, trust, dedication, and attention to detail.

Regulatory affairs plays a key role in our product life cycle by leading pre-market strategy, preparing regulatory submissions, and ensuring post-market compliance. Regulatory affairs must also work with international authorities and regulators wherever our medical devices are marketed. We take pride in our conformity to the highest international requirements for medical device companies and our compliance with international standards, including those of the FDA, CFDA, MFDS, PMDA, ANVISA, and the CE Mark.