על ידי arazygroup | אפר 20, 2020 | ללא קטגוריה
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. EUA Face Masks Intended for a...
על ידי arazygroup | מרץ 30, 2020 | ללא קטגוריה
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...
על ידי arazygroup | פבר 18, 2020 | ללא קטגוריה
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...
על ידי arazygroup | אוק 23, 2019 | ללא קטגוריה
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...
על ידי arazygroup | ספט 27, 2019 | ללא קטגוריה
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...
על ידי arazygroup | ספט 19, 2019 | ללא קטגוריה
2019 MedTech Regulatory Award 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...
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