Medical Devices

Medical Device Consultants – Engineering

Medical Device Consultants

Engineering related medical device consultants can come from a lot of different areas. These span from science degrees like microbiology and physics, innovation degrees such as product design and implant design and …

ISO13485:2016 TGA requirement

ISO 13485:2016 – The race is on…

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 …

3D-printer

Custom Medical Devices TGA / ISO 13485:2016 Certification

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 …

gap-analysis

Free ISO 13485:2016 Gap Analysis

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 …

ISO 13485:2016 Templates For Sale

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 …

ISO 13485 2016 is here… what now?

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 …