by Tim Bubb | May 23, 2023 | IMed Consultancy, PMS, USA
Medical device product fault reporting the to the US FDA STAY IN THE KNOW Sign up to get the latest updates. Don't worry.... we don't like spam either Success! Name Email Subscribe Do I need to report a medical device product fault to the US FDA? In the unfortunate...
by Tim Bubb | May 9, 2023 | IMed Consultancy, MDR, PMS
EU Post Market Surveillance – Transitional Requirements for Medical Device Manufacturers 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 transition of the medical device industry in the...
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 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 14, 2023 | IMed Consultancy, MDR, PMS
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...
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...