Medical Devices

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 …

TGA medical devices

The Medical Device Single Audit Program

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, …

Comparison of Medical Device Standards

Whitepaper – ISO13485 & US FDA CFR 820 Comparison

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 …