Transition Plan and Regulatory Changes for Software as Medical Devices

In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods...
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including: new classification rules for...
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TGA published review of safety and performance issues in Medical Device software

Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased in complexity and usage. The...
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Software as a Medical Device – Upcoming Changes to the Australian Regulations

With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020. Since the...
Article: EU Software Classification under MDR/IVDR – New Guidance Documen

EU Software Classification under MDR/IVDR – New Guidance Document

In October 2019 the Medical Device Coordination Group (MDCG) released a new guidance document on Qualification and Classification of Software in the European Regulations 2017/745 – MDR and 2017/746 –...

Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the Apple Watch. FDA cleared both...

Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...


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