by Stephen Quinn | Mar 31, 2021 | IVD
IVDR Language Requirements STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe The diverse range of live European languages presents a few challenges in determining which languages are required,...
by Catriona Underwood | Mar 24, 2021 | IVD, MDR
What’s going on with Medical Devices Down Under? STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe So what’s going on with Medical Devices Down Under? We’ve got Brexit’s...
by Al Mills | Mar 17, 2021 | IVD, MDR
3 things to consider on your medical device regulatory strategy – post Brexit STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Do you know how rapid regulatory changes and issues like...
by Stephen Quinn | Mar 10, 2021 | IVD
Tackling Medical Device Software Under the New IVDR Requirements (Part 2) STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe In part 1 of tackling medical device software under the new IVDR...
by Stephen Quinn | Feb 24, 2021 | IVD
COVID-19: How IMed is Supporting the Industry STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Here at IMed, our Quality & Regulatory Consultants have been busy adapting to the challenges...
by Stephen Quinn | Feb 3, 2021 | IVD
Tackling Medical Device Software Under the New IVDR Requirements (Part 1) STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe The definition of an IVD in Article 2 of the IVDR 2017/746 states: ‘in...
by Stephen Quinn | Jan 27, 2021 | IVD
IVDR: The intended purpose (for beginners & those experienced with IVDD) STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe And in the beginning, there was the intended purpose… and once...
by Stephen Quinn | Jul 24, 2020 | IVD
STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe As the manufacturer of legacy IVD devices, you face the challenge of reclassifying your product portfolio using the new risk-based...
by Stephen Quinn | Jan 10, 2020 | IVD
EU IVD Regulation: every part of the supply chain has a new set of obligations to legally abide by STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe It is quite an easy assumption to make, that...
by Stephen Quinn | Sep 2, 2019 | IVD
New European IVDR: What are the key areas of change to focus on? With only 144 weeks left until the application date of EU 2017/746 for IVDR, your business needs to be prepared. This might seem like plenty of time to get everything in order and ready for the...
