Arazy Group Blogs and Case Studies 

LICENSALE Mobile Now Available!

LICENSALE Mobile Now Available!

Medtech Registration Just Became Mobile LICENSALE® Mobile is now available on the App Store and Google Play. Login with your portal registration credentials to view your registration projects from anywhere.  View your products' real-time marketing statuses...

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Israeli Regulatory Pathway to the UAE

Israeli Regulatory Pathway to the UAE

UAE - Medical Device Registration for Israeli Companies The recent peace agreement brings immediate commercial opportunities for Israeli medical technology in the United Arab Emirates and through it to other members of the Gulf Cooperation Council (GCC). Arazy Group...

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18 Days to Traditional FDA 510(k) Clearance

18 Days to Traditional FDA 510(k) Clearance

Arazy Group’s Fastest Clearance 18 Days for Traditional FDA 510(k) Clearance via the “Triage Quick” Program. On August 14, 2020 Arazy Group received its fastest Traditional 510(k) clearance via the FDA’s new expedited 30-day Triage Quick route. This is an option that...

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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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    Dictum Health

    Dictum Health

    October 2020 | Dictum Health – Canada – PR of IDM100 Medical Tablet ...
    Versah LLC

    Versah LLC

    October 2020 | Versah LLC – Moldova – PR of Densah Burs & Tapered Pilot Drill and Universal Bur Holder & Parallel Pins ...
    Schiller AG

    Schiller AG

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

    Terragene

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

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