Regulatory Compliance



"Our commitment is to provide excellent products & services that exceed the standard of simply meeting the customer's expectations or complying with various regulations or specifications."


We strive to be a World Leader in Bioresorbable Scaffold Tissue Engineering by using Cutting-Edge Technology. We believe in “Empowering Natural Tissue Regeneration” through the development of new scaffolds technologies and manufacturing medical devices which will repair and regenerate tissue that is both safe and effective while complying with all regulatory requirements for use.

Comformance Standards

Sterilisation

ISO 11137

Packaging

ISO 11607

Quality systems

ISO 13485
(Certified in July 2007)

FDA QSR 820 MDD
93/42/EEC Annex II.3

Clean Room

ISO 14644-1

Sterilisation

ISO 11137

Biocompatibility

ISO 10993