Imedconsultancy.com

Compassionate Use and Temporary Use of a medical device

Medical devices should always be used as described and as intended by the manufacturer. This should be clear on the device, on the packaging and in the instructions. But if … See more

Actived: 4 days ago

URL: https://imedconsultancy.com/compassionate-use-and-temporary-use-of-a-medical-device/

MDCG Guidance on Substantial Modification of Clinical Investigation

WEBThe latest MDCG Guidance (2021-28) explained. Earlier this month, December 2021, the MDCG published a new guidance document alongside an …

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Are you ready for the changes to Canada’s medical device …

WEBThere are also new regulatory powers, set out in the following sections of the Canadian Medical Devices Regulations: Section 21.1 – Power to require and …

Category: Medical Go Health

How to advertise your medical devices in the UK and avoid …

WEBThe control of advertising medical devices in the UK is based on a system of self-regulation. This is supported by the statutory role of the UK Competent Authority, …

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Medical device product fault reporting the to the US FDA

WEBFDA has published a useful guidance document, which should be used to help manufacturers determine whether a device problem needs to be reported to them. …

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Digital Technology Innovation and Medical Devices

WEBUK proposes £3.5 billion of funding and innovative new device pathways for Medical Devices and Digital Health incorporating Artificial Intelligence

Category: Medical Go Health

Medical Device Field Safety Corrective Actions

WEBThe steps involved in completing an EU Field Safety Corrective Action notification. Are generally considered to be; Collate sales and distribution information on …

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Software as a Medical Device

WEBAt IMed, we do things a bit differently – investing time in getting to know our clients and their businesses. We value the business they give us of course, but we also respect the trust …

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The Power of Partnerships

WEBAt this time of year, Expo Season gives way to holidays. In the madness of following up all the exciting innovators and new strategic partners I met on my recent …

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Medical Device Global Market: Expanding into Asia-Pacific (APAC)

WEBAsia-Pacific (APAC) The Asia Pacific area has some of the world’s most populated countries making up over 60 percent of the global population. Market data …

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Key MDCG Guidance Documents for a Clinical Evaluation (EU MDR)

WEBWhen producing a Clinical Evaluation for a medical device under the scope of the EU MDR 2017/ 745, MDCG guidance documents play a crucial role in enabling …

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University Hospital Southampton

WEBIMed Consultancy: supporting NHS-born innovation with University Hospital Southampton – In his role of Head of Commercial Innovation at University Hospital …

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The early screening imperative

WEBThe early screening imperative: the UK regulatory landscape for IVDs. In the aftermath of the Covid-19 pandemic many national health services have been left with …

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When and how to report a medical device product fault to EU …

WEBAddress: IMed Consultancy Ltd. Bloxham Mill Business Centre Barford Road, Bloxham Banbury, Oxfordshire OX15 4FF United Kingdom

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IMed Consultancy supports women scientists and entrepreneurs in …

WEBThis October 10 th, on Ada Lovelace Day (ALD) which is an international celebration of the achievements of women in science, technology, engineering and maths (STEM), IMed …

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SureScreen Diagnostic

WEBSureScreen Diagnostics is an award-winning business providing quality rapid diagnostic equipment and services around the globe. Across Europe, every two …

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