by arazygroup | Sep 27, 2019 | Blog
Arazy Group Consultants is honoured to receive recognition as one of the TOP 10 Consulting Companies by MedTech Outlook’s Editorial Board with support from medical equipment manufacturing technology veterans and industry analysts. Arazy Group was selected... by arazygroup | Sep 19, 2019 | Blog
2019 MedTech Regulatory Award Recipients The second annual MedTech Regulatory Awards will take place the evening of September 23rd in Philadelphia. This year, the night will focus on the overall outstanding contributions of regulatory professionals and their... 
by arazygroup | Sep 11, 2019 | Blog
Regulatory Update- USA FDA September 2019 NEW STANDARD: AAMI TIR102:2019 U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems. This document provides a mapping of the US FDA 21 CFR requirements to... 
by arazygroup | Aug 16, 2019 | Blog
Regulatory Update- MDR 2017/745 August 2019 The EU Commission recently released Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8. This document provides additional guidance in relation to the Medical Device Vigilance System that... 
by arazygroup | Aug 8, 2019 | Blog
Regulatory Update- MDR 2017/745 July 2019 The new EU medical device regulations (MDR 2017/745) are almost here. They will be going into effect on May 2020 and will affect all medical devices. The focus of this document is the class I self-declared devices, which are... 
by arazygroup | Jun 14, 2019 | Blog
AMRA is a ground-breaking, international digital health company at the forefront of medical imaging and precision medicine. The company has developed a new global standard in body composition assessment, delivering multiple fat and muscle biomarkers with unrivaled...
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