Our team have managed the development of Healing Chambers International and are poised to enter the market.
Our team have invested heavily in the business to date and now we seek an injection of the financial capital we need from a suitable investment partner to take the business to their next stage. Having gained this finance, we would immediately action the following tasks:
Our devices are ready for manufacture with our internationally certified manufacturing partners. They have been designed according to international certification standards and manufacture of the initial batch of prototype chambers is scheduled to take 6 months.
Stage 2 Audit of ISO 13485:2016
As part of the manufacturing process, detailed testing and engineering reports are compiled. These reports, figures and observations which make up the bulk of the content necessary for the Stage 2 Audit of our Quality Management System conforming to ISO 13485. Our QMS has passed a Stage 1 Audit by leading international certifying body, British Standards Institute.
Technical File / Design Dossier to CE MDD
As above, much of the qualifying content for the ‘Design Dossier’ / ‘Technical file’ required to apply for the internationally recognised sign of quality assurance, the CE Mark, is created during the manufacture process (eg. engineering testing reports). Established especially for the medical industry, compliance with the CE Medical Device Directive (CE MDD) allows a company to display this mark on their product. Being registered with CE MDD allows direct recognition in many country’s medical device registers (eg. the Australian Register of Therapeutic Goods).
FDA for 510K clearance
To enter the US market, the device has to be approved for pre-market notification through the Food and Drug Administration (FDA). A 510(K) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre-market approval.