Great innovation has come out of small Australian companies who have developed of novel medical devices. These companies then realise that the regulatory process of compiling conformity assessment dossiers is a complex and lengthy process. Good regulatory advice at the start of the product development process could save a lot of tears and skilled practitioners are required to marshal the products through the regulatory minefield. TGA and EU requirements are very close.
This session recounts experiences of an Australian company in taking products through CE certification, and the regulator in evaluating conformity assessment dossiers.
Chairperson: Dr Clive Simon, Principal Consultant – Regulatory Affairs, Product Development and QA, The SPD Company