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. EUA Face Masks Intended for a...
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...
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...
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...

Announcing the 2019 MedTech Regulatory Awards Recipients

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...