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Digital Technology Innovation and Medical Devices

Digital Technology Innovation and Medical Devices

UK proposes £3.5 billion of funding and innovative new device pathways for Medical Devices and Digital Health incorporating Artificial Intelligence The UK government is currently looking at reforming the UK regulatory system for medical devices, to increase the...

Key steps to Post-Market Surveillance (PMS)

Key steps to Post-Market Surveillance (PMS)

Medical device businesses need to stay on top of their Post-Market Surveillance activities at all times. There are some specific areas to focus on to help ensure that PMS is up to date and thorough, in this blog IMed Consultancy shares some must-monitor areas for...

PMS and patient safety: shifting to a proactive approach

PMS and patient safety: shifting to a proactive approach

Despite deadlines for the EU MDR 2017/745 and the EU IVDR 2017/746 (IVDR) implementation being pushed back once more, certain aspects of the MDR that are closely linked to patient safety, such as the need for cyclical and proactive Post Market Surveillance (PMS), are...

Compassionate Use and Temporary Use of a medical device

Compassionate Use and Temporary Use of a medical device

Easement or relaxation of certain regulatory requirements Relaxation of certain regulatory requirements (‘easement’) was well recognized and utilized for devices (e.g., masks, gloves, ventilators) and IVD’s such as lateral flow tests during the earlier phases of the...

Medical Device Field Safety Corrective Actions

Medical Device Field Safety Corrective Actions

EU lay of the land  Medical devices, like all products can potentially go wrong. Robust processes are usually in place at manufacturing organisations to help prevent safety problems, but even the best designed product can be found later to have unexpected design or...