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 | 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...
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...
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...
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...
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...
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...
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...