Arazy Group Blogs and Case Studies 

Regulatory Update – COVID-19 Fast-Tracking

Regulatory Update – COVID-19 Fast-Tracking

Fast- Track under COVID- 19 for Health Canada & FDA Health Canada For manufacturers that want to fast-track under Covid-19, the medical device must be manufactured, sold or represented for use in relation to severe acute respiratory syndrome coronavirus 2...

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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 ready...

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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 CLASS I MEDICAL...

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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...

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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...

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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...

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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...

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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...

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    Schiller AG

    February 2020 | Schiller AG – USA – PR of Cardiovit AT-102 G2 ...
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    Terragene

    September 2019 | Terragene – USA – PR of Chemdye ...

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