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.

Device Performance

The device is a Bone Void Filler, for the augmentation or restoration of body contour. The shape of the device conforms with the defect, thus maximizing direct contact with viable host bone.

The device is made of polycaprolactone which will degrade and resorb fully in vivo by hydrolysis into which it is then metabolized by the body, over a period of 18-24 months.

Contraindications:

  1. Do not use in patients with conditions including latent or active infections, systemic disorders which will hinder wound healing, or with insufficient quantity or quality of bone stock.
  2. Do not use in contaminated surgical areas.
  3. Do not use in patients with septic reactions.
  4. Not indicated for load bearing anatomical sites.
  5. Do not use in areas exposed to outside environment.

Conformance 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