Worked with healthcare professionals to develop the disposable laparoscopic device and OR accessories.
Silver Metal Award of Taipei Biotech Research & Development Innovation
Industry Facility Established
ISO 13485 Certification
Taiwan GMP Certification
CE Marking Medical Devices(MDD 93/42/EEC) Certification
Korea KGMP Certification
ISO 13485:2016 Certification
First FDA 510(k)
Our guarantee -
Quality system management is in accordance with ISO 13485:2016.
Product establishment is in accordance with the section 7.3 design and development of ISO 13485:2016.
Product production and release is in accordance with the section 7.5 production and service provision of ISO 13485:2016.
Conduct the risk management is in accordance with ISO 14971:2012.
FDA certified manufacturer