To prepare ourselves for international market entry we have invested in excess three years of business development to reach the point we are at.
Benefitting from direct experience in the HBOT market, and having completed detailed market research, we have completed designs of the world’s most contemporary medical device in this field.
With input from experienced medical professionals, expert businesspeople, industry consultants, internationally certified pressure-device engineers and industrial designers, we have commenced manufacture of our first batch of Oxylife 110 chambers (4 of which are under pre-order for a clinic in Australia and 10 for clinics in the United States).
- Written an internationally compliant Quality Management System for medical device manufacturers (ISO 13485)
- Authored a Clinical Evaluation Report based on 50 years worth of clinical trials and analysis
- Established a Risk Assessment and Management Plan for the manufacture of medical devices (ISO 14971)
- Detailed Process Flow Charts (for purchasing, receiving, assembly, installation and maintenance)
- Completed detailed Customer Clinics Requirements and exacting treatment protocols
– all of which have passed a Stage 1 Audit through British Standards Institute with outstanding feedback.
Once the manufacturing has been completed and engineering reports are at hand, we can progress to:
- 2nd Stage Audit of ISO 13485
- CE Medical Device Directive (93/42/EE)
- CE Pressure Equipment Directive (97/23/CE)
- Clearance for FDA 510k
- Final certification for ASME-PVHO-1
We have established relationships with AusTrade and international distribution channels targeting existing Free Trade Agreements.