Got a Great Idea for a Health App? It Might Need Regulation
If you’ve ever wondered what it takes to turn ‘one good idea’ into an app or piece of software that makes a difference to the health and wellbeing of others, it might surprise you to learn that it may be a medical device and so it might need regulatory approval. Software as a Medical Device […]
Medical device terms and jargon
The medical devices industry is regulated and therefore there are many medical device terms that have specific meaning defined in the legislation. For example, in Australia, the Therapeutic Goods Act 1989 or the Therapeutic Goods (Medical Devices) Regulations 2002 give some words a specific definition. Other jurisdictions such as the USA and Europe have different […]
It’s time the Australian Government addresses the medical device double standard
When the European Union moved to replaced the outdated Medical Devices Directive (MDD) with the Medical Devices Regulation (MDR) back in 2017, it was hoped a staggered transition period to 2021 would allow ample time for medical devices to be re-assessed and recertified under updated regulatory standards.
Platypus MedTech Consultants Pty Ltd
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enquiries@platypusmedtech.com.au