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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 […]

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 […]

With the transition period for updated regulations around Software as a Medical Device (SaMD) in Australia well and truly over, it’s a timely reminder of the need for users of software medical devices – including health-related apps – to know what these products are, and why they’re required to meet strict criteria. SaMD is not […]

When the European Union moved to replaced the outdated Medical Devices Directive (MDD) with the Medical Devices Regulation (MDR) back in 2017, it was hoped a staggered transition period to 2021 would allow ample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. 

Broadly speaking, a medical device is considered to be any article that is not a medicine, and that is used for the diagnosis, prevention, monitoring, treatment or alleviation of a health condition.

Document control systems for quality management do not need to be complex, difficult or expensive.  They just need to meet the requirements of standards and regulations, which are usually quite flexible.  You can get simple but effective document control software setup with sensible configuration of commercial grade document systems, such as Sharepoint.  This not only saves you money when you are small and cash-strapped, but get yous started in quality manager early, which is always cheaper than starting late.

Most medical device regulators require medical devices to be designed and manufactured under a Quality Management System (QMS), they also require risk management of the product. So how do you build a QMS? Where do you start?

Watch the video below to learn how to start.

Medical device regulation can be complex, depending upon the product. However, it is often not what people expect because the focus managing risk and quality, rather than telling you what features are allowed.

Validation is a vital concept when it comes to proving what things do.  It is a term commonly used by engineers, scientists, physicians and other people working in evidence based professions.  Validation is also a vital part of product quality assurance.  I usually need to explain how I have validated a new method or tool […]