February 2020 MDR 2017/745 Regulatory Update

February 2020 MDR 2017/745 Regulatory Update

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...
Regulatory Update #191001 – CE MARK

Regulatory Update #191001 – CE MARK

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...

Announcing the 2019 MedTech Regulatory Awards Recipients

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...
Regulatory Update #190901– USA FDA

Regulatory Update #190901– USA FDA

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...
Regulatory Update #190801– MDR 2017/745

Regulatory Update #190801– MDR 2017/745

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...