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 want to bring “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.

Conformance Standards

Sterilisation
ISO 11137
Packaging
ISO 11607
Quality systems
ISO 13485

FDA QSR 820

MDD 93/42/EEC Annex II.4
CleanRoom
ISO 14644-1

Biocompatibility
ISO 10993