Bio Nova is fully accredited to ISO 13485 as a medical device manufacturer.

The manufacturing facilities are licensed by the Australian Therapeutic Goods Administration (TGA), TÜV Rheinland Product Safety GmbH (the European Notified Body responsible for CE Mark) and TUV North America on behalf of the Canadian Health Ministry and are subject to regular audits from all bodies.

 

Certifications may be downloaded here:

	Conformity Assessment Certificate – Full Quality Assurance Procedures Issued by the Australian Therapeutic Goods Administration (0.5 MB)
	Conformity Assessment Certificate – Design Examination Issued by the Australian Therapeutic Goods Administration (0.5 MB)
	EC Design Examination Certificate (1 MB)
	Full Quality Assurance System Approval Issued by TÜV Rheinland Product Safety GmbH, Germany (0.4 MB)
	ISO 13485:2003 Certificate Issued by TÜV Rheinland of North America, Inc. (0.5 MB)
	Health Canada Medical Device Licence (0.2 MB)