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 IMed Consultancy | Jul 18, 2023 | IMed Consultancy, IVD, New Markets
Deep Dive in the Asia Pacific Medical Device Market – China STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Welcome back to our articles dedicated to emerging market access. This time we...
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 IMed Consultancy | May 2, 2023 | IVD, PMS, UKRP
Planning and Process for Compliant Post-Market Surveillance STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro...
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 IMed Consultancy | Mar 9, 2023 | IMed Consultancy, IVD, MDR, New Markets, PMS
Medical Device Global Market: Expanding into Asia-Pacific (APAC) STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Daniel English, Regulatory Affairs Consultant at IMed Consultancy provides...
by IMed Consultancy | Mar 1, 2023 | IMed Consultancy, 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 Jonathan Ripley | Dec 1, 2022 | Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS, swiss, UKRP
Switzerland’s Parliament Moves to Accept FDA approved 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 On the 28 Nov 2022, Switzerland’s Parliament took a decision to...
