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Regulatory

ISO 13485 Quality Management System

Applied Physiology is implementing ISO 13485 Quality Management System .

Regulatory Submissions

Applied Physiology has obtained TGA Certification and CE marking for Navigatorâ„¢ and is approved for sale in Australia and the European Union. The company has also completed the necessary regulatory applications in order to obtain regulatory clearance in the USA. 

Regulatory advice is provided by Kea Imgraben of KD&A www.kdas.com.au