Arazy Group Blogs and Case Studies
UK MHRA: Regulating Medical Devices Starting January 1st, 2021
As of January 1st 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator. See the new guidelines here
Israeli Regulatory Pathway to the UAE
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 Consultants Inc. has been operating in these markets for the past eight years registering medical and IVD devices.
18 Days to Traditional FDA 510(k) Clearance
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 the Triage Quick program is offering any Traditional 510(k) submission that meets its criteria. The Traditional 510(k) submission, K202068, which was sent for Triage Quick review on July 27, 2020 and was cleared only 18 days later.
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...
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...
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...
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...
Arazy Group Named Top 10 Medical Device Consulting Company 2019
Arazy Group Consultants is honoured to receive recognition as one of the TOP 10 Consulting Companies by MedTech Outlook's Editorial Board with support from medical equipment manufacturing technology veterans and industry analysts. Arazy Group was selected as a ...
Announcing the 2019 MedTech Regulatory Awards Recipients
The second annual MedTech Regulatory Awards will take place the evening of September 23rd in Philadelphia. This year, the night will focus on the overall outstanding contributions of regulatory professionals and their work leading to achievements in approvals....
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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