SaMD

shutterstock_1498578428 web

Software as a Medical Device – Upcoming Changes to the Australian Regulations

By Belinda Dowsett | 29 May, 2020
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...
Software

EU Software Classification under MDR/IVDR – New Guidance Document

By Yervant Chijian | 28 October, 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 –...
apple-watch-3-2

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

By Arthur Brandwood | 11 October, 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...
Watch

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

By Luis Jimenez | 27 September, 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...

Search

Recent Posts

Harmonised Standards for MDR? CEN/CENELEC say “Non”

Jul 2, 2020

FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

Jul 1, 2020

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

Jun 19, 2020

Proposed delayed commencement of certain Medical Device Regulatory Changes

Jun 12, 2020

Software as a Medical Device – Upcoming Changes to the Australian Regulations

May 29, 2020

Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods

May 19, 2020

Categories

Categories

Archives

Archives

Archives

Tags

510(k) APAC Australia Biocompatibility Brexit CE CE Certificates clinical trials coronavirus COVID19 de novo distribution EU Europe FDA GHTF Harmonization IMDRF IVD IVDD IVDR MDD MDR MDSAP medical device Medical Device Regulations medical devices medicines MHRA New Zealand Notified Bodies PMA PMDA postmarket private health insurance QMS Quality Systems Reform regulatory Reimbursement SaMD Software standards TGA UDI