Arazy Group Blogs and Case Studies 

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...

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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...

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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...

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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...

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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...

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Top MedTech Events You Need to Attend in 2019

Canada’s MedTech Conference Date: April 3-4th, 2019 Location: Mississauga, ON This Canadian conference was designed to create a better understanding of the current initiatives in healthcare and how MedTech can contribute to these initiatives. There will be sessions...

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RDC 270/2019 Summary

Changes for Low Risk Devices in BrazilAs of May 2019, there will be a new registration notification pathway allowing medical device manufacturers to access the Brazilian market quicker. The recently published RDC 270/2019 establishes this new notification pathway...

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