by Tim Bubb | Aug 22, 2023 | EU, IMed Consultancy, MDR
When and how to report a medical device product fault to EU regulators 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 I need to report a medical device product fault to EU regulators? All...
by Jade Fraser | Aug 3, 2023 | IMed Consultancy, IVD, MDR, UKRP
CE Marking Changes in the UK: highlights and pointers for MedDev manufacturers STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe On the 1st August 2023, the UK Government announced that...
by Tim Bubb | Jun 27, 2023 | IMed Consultancy, IVD, MDR
Post Market Clinical Follow up, what is this and what do I need to do? STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Over the last few years there has been an increasing focus from medical...
by Tim Bubb | May 9, 2023 | IMed Consultancy, MDR, PMS
EU Post Market Surveillance – Transitional Requirements for Medical Device Manufacturers 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 transition of the medical device industry in the...
by Matt Burton | Apr 27, 2023 | MDR
Borderline products and the new UK Medical Device Regulations: what’s changing? 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 MHRA intends to bring certain aesthetic and another...
by Matt Burton | Apr 18, 2023 | IMed Consultancy, IVD, Legacy devices, MDR
Medical device legacy status: new definition and 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 In March the European Commission reached a decision regarding the MDR/IVDR...
by IMed Consultancy | Apr 4, 2023 | IVD, MDR, PMS
PMS and patient safety: shifting to a proactive approach STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Despite deadlines for the EU MDR 2017/745 and the EU IVDR 2017/746 (IVDR)...
by Matt Burton | Mar 22, 2023 | IMed Consultancy, IVD, MDR, New Markets, PMS, UKRP
UKCA opportunity – A compelling case for UK market access and commercial opportunity 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 medical device regulatory environment is undergoing...
by Tim Bubb | Mar 20, 2023 | IMed Consultancy, MDR
Digital Technology Innovation and Medical Devices STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe UK proposes £3.5 billion of funding and innovative new device pathways for Medical Devices and...
by IMed Consultancy | Mar 14, 2023 | IMed Consultancy, MDR, PMS
Key steps to Post-Market Surveillance (PMS) STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Medical device businesses need to stay on top of their Post-Market Surveillance activities at all...
