With the Olympics still fresh in our minds, it seems fitting that the TGA announced their race times for the complete implementation of ISO 13485:2016 certification as opposed to ISO 13485:2003 acceptance. On your marks… In a recent blog, Custom Medical Devices TGA / ISO 13485:2016 Certification, we discussed the benefits and requirements of implementing…
Do I really need ISO 13485:2016 certification? There has been rapid growth in the area of custom-made medical devices, made for single known, patients and this has led to the authorities issuing additional guidance. Innovative companies around the world are producing devices and drugs such as Anatomics and Aprecia* using technologies such as 3D printing. *Note: In March 2016,…
PharmOut recently developed a free ISO 13485:2016 Gap Analysis tool for identifying the gap between the ISO 13485:2016 and ISO 13485:2003, currently this tool is free to all clients attending our ISO 13485:2016 Medical Device training, or anyone that may have previously purchased our ISO 13485:2003 QMS templates since the 1st January 2016. The latest…
Seamus Orr Lead Consultant, offered the first ISO 13485:2016 training in Australia and New Zealand, now we are offering ISO 13485:2016 Templates for sale, our customers describe the templates as follow – “Your templates are the most high-level (as well as attractive and professional looking) of all the templates I am finding online. They are nearly double…
This very practical question seems to be on everyone’s lips, ‘ISO 13485 2016 is here, what do we do now?’ With a three year transition period proposed (N233 Draft White Paper – ISO Transition Planning Guidance for ISO13485:2016) and ISO 14971 Software, Quality and Risk Management of Medical Devices also now mandated, the Australian medical…
Another Major Milestone for Vaxxas’ Revolutionary Vaccine Delivery Platform. Queensland-based Biotech company Vaxxas certainly embodies the Australian Government’s innovation strategy – “the ideas boom”. Their Nanopatch™ product is an innovative vaccine delivery platform, with many exciting benefits over traditional delivery methods, perhaps most notably in the developing world, who are rarely the early beneficiaries of…
The BioMelbourne Network event on Wearable Medical Devices and Diagnostics that PharmOut attended in Melbourne on March 17th certainly confirmed the two directions that wearables and wearable devices in medical technology are currently taking. On one path are devices and apps that residue in a “pre-diagnostic world”, supplying users with information on sport and fitness,…
Be the first in the know. Join our devices expert Seamus Orr in Melbourne and Sydney for ISO 13485 : 2016 Training Course Some regulatory and standard version updates are anticlimactic – years of review and then the key changes are semantics that leave manufactures still pondering intent. This is not the case for ISO…
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