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EU Software Classification under MDR/IVDR – New Guidance Document

By Yervant Chijian | 10.28.2019
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 –...
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Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

By Arthur Brandwood | 10.11.2018
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...
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Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

By Luis Jimenez | 09.27.2018
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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Recent Posts

TGA acceptance of international device reviews – clearing the fog

Dec 20, 2019

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

Dec 19, 2019

A single review program for medical devices?

Dec 2, 2019

The door to Europe is closed – so where else should I look?

Dec 2, 2019

Are Harmonised Standards facing irrelevance?

Nov 4, 2019

The question on clients’ lips… “How long will my application take?”

Nov 4, 2019

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