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...
Regulatory Update #190701- MDR 2017/745

Regulatory Update #190701- MDR 2017/745

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...
FDA Series- AMRA Medical

FDA Series- AMRA Medical

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...
FDA Series- ETGAR Medical Instruments

FDA Series- ETGAR Medical Instruments

Late last year, the Dental Implants: Global Markets to 2023 report, was published detailing the industry’s expected high competition levels and a market to exceed US $6.5 Billion by 2024. With this industry quickly growing, Arazy Group Consultants is excited to work...