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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MARI%™スコアとは

MARI%™-マーケット準備指標アクセススコア (1-100%)   新しい市場へ進出する際、現在既に手元にあるコンプライアンス文章だけでどれほど準備が完了しているのか。この答えがMARI%™にあります。さらに今年の年末には新Licensaleシステムによる新マーケット準備指標スコアを発表する予定です...

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グローバル登録マップ(GR-MAP™)とは

グローバル登録マップ(GR-MAP™)とは 複数の国にまたがって医療機器承認/登録業務を行う際、作業管理が煩雑になりがちです。そのためそれぞれの市場でライセンスの維持、更新、移転、修正に必要な手続きを瞬時に正確に把握できることはとても大事です。...

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