Medical Devices

medical-device-regulation-mdr

Medical Device Regulation (MDR) – 11 Key Changes

The EU Medical Device Regulation (MDR) is the most significant regulatory change in Europe in over 20 years. The MDR will replace the Medical Device Directive 93/42/EEC, effective 26th May 2020. The MDR entered …

software-as-a-medical-device

Software as a Medical Device (SaMD)

SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is …

vial-inspection

5 Things to Know About MDSAP in 2020

What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements …

Validation Consultants

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 …

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 …