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...
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...