Medical Devices


Clinical Evaluation EU-MDR requirements

Clinical Evaluation EU-MDR requirements 
This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR . 
What is meant by the term ‘clinical evaluation’ in the EU MDR? 
The EU Medical Device …


ISO 22442 – Medical Devices containing animal materials

Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials.

The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or …


Brexit and Medical Devices Regulation in the United Kingdom

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union.

What does this …


Custom-Made Medical Devices | Changes – February 25, 2021

Personalised medical devices cover a range of products. Custom-made medical devices are medical devices designed and made as specified by a health professional to be used by a specific individual. They are not to be confused with mass-produced off-the-shelf …


Medical Device Regulation (MDR) – 11 Key Changes

The EU Medical Device Regulation (MDR) was the most significant regulatory change in Europe in over 20 years.

The MDR entered into force in 2017 with a three-year transition period.*
The MDR replaced the Medical Device Directive 93/42/EEC and …


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 regulated under the existing medical …


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 of the pilot program in …

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 also a range of engineering …

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 a recent blog, Custom Medical …