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Planning and Process for Compliant Post-Market Surveillance

Planning and Process for Compliant Post-Market Surveillance

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...
Medical device legacy status: new definition and requirements

Medical device legacy status: new definition and requirements

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...
PMS and patient safety: shifting to a proactive approach

PMS and patient safety: shifting to a proactive approach

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)...
UKCA opportunity – A compelling case for UK market access and commercial opportunity

UKCA opportunity – A compelling case for UK market access and commercial opportunity

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...
Medical Device Global Market: Expanding into Asia-Pacific (APAC)

Medical Device Global Market: Expanding into Asia-Pacific (APAC)

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...
PMS and patient safety: shifting to a proactive approach

PMS and patient safety: shifting to a proactive approach

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)...
Switzerland’s Parliament Moves to Accept FDA approved Medical Devices

Switzerland’s Parliament Moves to Accept FDA approved Medical Devices

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...
How to advertise your medical devices in the UK and avoid enforcement.

How to advertise your medical devices in the UK and avoid enforcement.

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...
IVDR Transition and Notified Bodies…… Early engagement is still critical!

IVDR Transition and Notified Bodies…… Early engagement is still critical!

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...
Have you appointed the right UKRP? Part 3

Have you appointed the right UKRP? Part 3

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...
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