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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 2

Have you appointed the right UKRP? Part 2

by Matt Burton | Dec 1, 2022 | Academy, Clinical Writing, IMed Consultancy, MDR, Medtech Marketing, UKRP

Have you appointed the right UKRP? Part 2 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 Medical Device or IVD...
Have you appointed the right UKRP? Part 2

Have you appointed the right UKRP? – Part 1

by Matt Burton | Nov 30, 2022 | Academy, Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS, UKRP

Have you appointed the right UKRP? – Part 1 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 Medical Device or IVD...
IVDR Transition and Significant Change…… What’s a Significant Change?

IVDR Transition and Significant Change…… What’s a Significant Change?

by Jonathan Ripley | Nov 30, 2022 | Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS

IVDR Transition and Significant Change…… What’s a Significant Change? STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Regulation (EU) 2017/746, IVDR, is in place, and the market is in a 2nd...
The Regulatory Framework in Switzerland – Ordinances and CH-REPs

The Regulatory Framework in Switzerland – Ordinances and CH-REPs

by Jonathan Ripley | Nov 30, 2022 | Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS, UKRP

The Regulatory Framework in Switzerland – Ordinances and CH-REPs STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Switzerland, though not a member state of the European Union, worked under a...
Webinar on UK Responsible Person Requirements – RAPS UK (LNG)

Webinar on UK Responsible Person Requirements – RAPS UK (LNG)

by Tim Bubb | Nov 30, 2022 | Clinical Writing, IMed Consultancy, IVD, MDR

Webinar on UK Responsible Person Requirements – RAPS UK (LNG) STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe   Timothy Bubb will presenting on the role of UK Responsible Person on...
Breaking: UK Software and Artificial Intelligence Regulation Roadmap for Medical Devices Published

Breaking: UK Software and Artificial Intelligence Regulation Roadmap for Medical Devices Published

by Tim Bubb | Nov 29, 2022 | Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS

Breaking: UK Software and Artificial Intelligence Regulation Roadmap for Medical Devices Published 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 UK medical devices regulator MHRA has...
Postmarket Surveillance

Postmarket Surveillance

by Jonathan Ripley | Nov 29, 2022 | Academy, Clinical Writing, IMed Consultancy, IVD, MDR, Medtech Marketing, PMS, UKRP

Postmarket 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 Six years after releasing draft guidance the FDA has released final guidance on device postmarket studies and postmarket...
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