by arazygroup | Feb 18, 2020 | Blog
May 2020 – MDR is less than 3 months away – Are you ready? We would like to help you with the latest updates from the EU market and make sure you are in line with the upcoming regulations. Commission News – The Delays It appears that the commission is not fully... by arazygroup | Oct 23, 2019 | Blog
Regulatory Update Class I Manufacturers – Protect Your CE Mark October 2019 This is a service message from Arazy Group Germany – A European Authorized Representative (EU AR) for Class I Medical and IVD Manufacturers. MDR /IVDR REQUIREMENTS FOR STANDARD... 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... 
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