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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...
Digital Technology Innovation and Medical Devices

Digital Technology Innovation and Medical Devices

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...
Key steps to Post-Market Surveillance (PMS)

Key steps to Post-Market Surveillance (PMS)

by IMed Consultancy | Mar 14, 2023 | IMed Consultancy, MDR, PMS, Uncategorized

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...
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)...
Countdown to the final UK MDR: changes Importers and Distributors need to be aware of

Countdown to the final UK MDR: changes Importers and Distributors need to be aware of

by Matt Burton | Feb 21, 2023 | IMed Consultancy, MDR, UKRP

Countdown to the final UK MDR: changes Importers and Distributors need to be aware of 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 final UK Regulation text is due to be published from...
Compassionate Use and Temporary Use of a medical device

Compassionate Use and Temporary Use of a medical device

by Matt Burton | Feb 17, 2023 | IMed Consultancy

Compassionate Use and Temporary Use of a medical device STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Easement or relaxation of certain regulatory requirements Relaxation of certain...
The new UK Medical Device Regulation is due soon: is your appointed UKRP ready?

The new UK Medical Device Regulation is due soon: is your appointed UKRP ready?

by Matt Burton | Feb 8, 2023 | IMed Consultancy, MDR, UKRP

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 final UK Regulation text is scheduled to be published from Spring 2023, so manufacturers should be assessing their current provider to...
Medical Device Field Safety Corrective Actions

Medical Device Field Safety Corrective Actions

by Tim Bubb | Jan 18, 2023 | IMed Consultancy, Medtech Marketing

Medical Device Field Safety Corrective Actions STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe EU lay of the land  Medical devices, like all products can potentially go wrong. Robust processes...
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...
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Recent Posts

  • UKCA opportunity – A compelling case for UK market access and commercial opportunity
  • Digital Technology Innovation and Medical Devices
  • Key steps to Post-Market Surveillance (PMS)
  • Medical Device Global Market: Expanding into Asia-Pacific (APAC)
  • PMS and patient safety: shifting to a proactive approach

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