As a company, we believe that stringent regulatory and quality standards are not just benchmarks to be met, but foundations upon which we build trust and excellence.
Certifications and Standards
Viral Inactivation
Once our fixed tissue process is defined and validated.
| Submission Preparation | 2 years from inception |
| Audit | Process is ongoing |
Approved Arrangement for
Export Registration
required for fixed tissue to be sent to companies outside of Australia for non R&D usage
| Timings | Facility required |
| Facility required | Immediate on completion of ISO 13485 |
EDQM (fixed tissue only)
Once 13485 has been created (and submitted) we start EDQM process. A dossier of documents for expert review.
| Dossier Preparation + Review | 9 months (commenced May 2024) |
| Processing | 9 – 12 months |
ISO 13485, showing compliance for 22442
Define our products (fresh tissue and early stage fixed tissue), create our quality system, create procedures, specifications, location for office and lab.
| Submission Preparation | 9 months (commenced May 2024) |
| Audit | 9 – 12 months |
QMS Standards
Adhering to the ISO 13485 standards ensures we deliver the highest quality products and services to our customers, while also fostering innovation and staying ahead in a competitive market.
Bovine Pericardium
Pericardium tissue is fundamental to the engineering of structural leaflets in heart valves.