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...
by Matt Burton | Dec 1, 2022 | Academy, Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS, UKRP
How to advertise your medical devices in the UK and avoid enforcement. 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 control of advertising medical devices in the UK is based on a...
by Jonathan Ripley | Dec 1, 2022 | Academy, Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing
IVDR Transition and Notified Bodies…… Early engagement is still critical! STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe If you are currently providing a UKRP service or if you are an Ex-UK...
by Matt Burton | Dec 1, 2022 | IMed Consultancy, IVD, MDR, Medtech Marketing, UKRP
Have you appointed the right UKRP? Part 3 STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe This is the 3rd article in a 3 day, 3-part series which considers some of the upcoming changes to the...