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 …
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 …
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 …
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 …
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 …
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 …
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 …
Medical Device Data Systems
On the 9th February the FDA released the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (MDDS),’ Guidance for Industry and Food and Drug Administration Staff. …
In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, …
Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for …
