Southern Lights Biomaterials
Medical Devices - , Hawke's Bay, New Zealand
Southern Lights Biomaterials Employees
Southern Lights Biomaterials Details
Biomaterials for Regenerative MedicineSouthern Lights Biomaterials supplies medical device companies throughout the world with processed and semi-processed bovine biomaterials. We source bovine tissues exclusively from New Zealand and Australia, ranked by the World Organization for Animal Health as 'negligible risk' countries. Southern Lights Biomaterials' quality management system has been assessed and certified by BSI as compliant with the requirements of ISO 13485: 2003 for the scope of the design and manufacture of bovine tissue based biomaterials and supply of bovine materials in accordance with EN ISO 22442-2-2007. Our quality systems and standards-based processes result in tightly defined products, assisting customers to meet international regulatory standards for medical devices. Southern Lights Biomaterials holds a certificate of suitability (CEP), issued by the European Directorate for the Quality of Healthcare and Medicines (EDQM) for purified Type I collagen materials. This certifies that our materials meet the criteria in the monograph "products with risk of transmitting agents of animal spongiform encephalopathies in. 1483 of the European Pharmacopoeia". The certificate will assist our customers in meeting regulatory requirements for medical devices. We welcome you to visit the EDQM website for verification of the Certificate of Suitability relating to our Purified type I collagen material.
