CellAED® LifeSaver® set for global Certification as a Medical Device
The product is expected to be manufactured in Australia by RRR Manufacturing Pty Ltd, one of the businesses in the Rapid Response Revival group.
Federal Drug Administration (FDA) approval for the United States will be undertaken in parallel with CE Marking for Europe and Therapeutic Goods Administration (TGA) approval for Australia. Various markets in Asia and the Middle East also recognise the CE Marking, therefore registration for these regions will follow shortly thereafter.
‘We don’t anticipate any issues that would have us not achieve certification as required’, said Rapid Response Revival Chief Executive Officer Leanne Knowles.
This certification will allow people from hundreds of countries to access the product that has been designed to increase the survival rate of Sudden Cardiac Arrest (SCA) from less than 1% globally. Rapid Response Revival aims to achieve at least a 50% survival rate or more with the widespread use of the CellAED® product range in the coming years.
Rapid Response Revival has retained George Loizou from Compliance Management Solutions to oversee the medical device regulatory process. Loizou spoke about the project, ‘The CE Marking categorises and certifies all medical devices according to their intended purpose. The CellAED® LifeSaver® is an Automated External Defibrillator (AED) that has been miniaturised, and it performs the intended purpose of an AED. There’s already more than 50 years of clinical history for the design and functionality of an AED that is universally accepted, and thousands of AEDs have already been registered globally,’ he said.
The company’s CEO added, ‘Our engineers have referenced the key clinical research in the design and development of the product. We have put it through more than 2000 hours of functional testing, and we’ve undertaken significant R&D. We look forward to going through this important milestone in medical device certification.’
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