Arazy Group Blogs and Case Studies 

New FDA Guidance Document Changes- COVID 19

New FDA Guidance Document Changes- COVID 19

11 COVID-19 Guidance Documents were released by the FDA, allowing the distribution and use of certain medical devices with the omission of some regulatory requirements including premarket review. See below for specific product changes.FDA does not intend to object to...

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