RegIQ Solutions

05/22/2019

We're excited to attend the Boston Chapter Meeting today in Waltham, MA. Stop by the RegIQ table to learn about the latest innovation in regulatory compliance!

05/14/2019

EU Publishes First Corrigenda for MDR and IVDR in the Official Journal and Further Explains on UDI Requirements. Learn More:

In order to fix inconsistencies, errors and slightly correct the European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR, respectively), two corrigenda have been published in the Official Journal of the European Union on...

05/09/2019

Dont forget to stop by Booth 7 Regulatory Conference in Brussels on May 13th and 14th. Book an onsite meeting with RegIQ today and you will be entered into a drawing to WIN AN IPAD!: https://bit.ly/2UQ9Wk6

04/11/2019

We’ll be in Brussels, May 13-14 Regulatory Conference. Stop by booth 7 where we’ll be talking about Magellan, the latest innovation in regulatory compliance. Book an onsite meeting with RegIQ today and you will be entered into a drawing to WIN AN IPAD: https://bit.ly/2UQ9Wk6

02/28/2019

Are you attending IDS 2019 in Cologne, March 12-14 and want to learn about the latest innovation in regulatory compliance? Book a meeting with RegIQ and you will be entered into a drawing to WIN A FREE IPAD! Click Here: https://bit.ly/2SujEna

02/06/2019

ANVISA implements Cumprimento Eletrônico de Exigência electronic system. Learn more: http://ow.ly/YpfG30nAXPk

01/31/2019

BSI first UK notified body to achieve successful MDR designation. Learn more: http://ow.ly/zXrm30nwJfP

BSI was informed on January 21st, 2019 by the Medicines and Healthcare products Regulatory Agency (MHRA) that its UK notified body (0086) is the first in Europe to be designated to the new MDR (EU 2017/745)....

01/29/2019

Learn more about the latest updates on Medical Device Marketing Authorization (M**A) procedures in Saudi Arabia: http://ow.ly/YZfs30nuII8

Early December last year, the Saudi Food and Drug Authority (SFDA) released the Announcement (1) 12/2018 containing the latest updates on Medical Device Marketing Authorization (M**A) procedures. Being effective January 1st, 2019, Medical Devices Marketing Authorization...

01/21/2019

Are you attending 2019 in Dubai, January 28-31 and want to learn about the latest innovation in regulatory compliance? Book a meeting with RegIQ and you will be entered into a drawing to WIN A FREE IPAD! Click Here: https://bit.ly/2VYtZup

01/17/2019

FDA Proposes to End Temporary Extension of GUDID’s Grace Period to Improve UDI Data Quality. Learn more: https://bit.ly/2FGEnBp

01/07/2019

Did you know the Secretary of State for Health and Social Care has recently written to suppliers of Med Devices and consumables to update them on preparations for a potential no-deal Brexit? Learn more: https://bit.ly/2FeHQa4

The Secretary of State for Health and Social Care, Matt Hancock, has recently written to suppliers of Medical Devices and clinical consumables to update them on preparations for a potential no-deal Brexit. This letter explains what...

11/12/2018

A hot topic right now is Medical Device Single Audit Program (MDSAP) and how it can streamline your registration process. Did you already start the transition to MDSAP? The clock is ticking! Click Here to learn more:

As of January 1st, 2019, Health Canada will terminate the Canadian Medical Devices Conformity Assessment System (CMDCAS) program and Canadian Medical Devices Conformity Assessment System certificates will no longer be issued or accepted. To ensure a...