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...