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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 … See more

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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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Could you be limiting the sales of your medical device by not

WebSelf-Care. The combination of the increasing prevalence of chronic diseases and working through the challenges which the COVID-19 global pandemic presented for …

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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 the …

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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 disclose …

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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

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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 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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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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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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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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Entering the UAE medical device market – what you need to know

WebThe UAE is made up of seven emirates including Abu Dhabi and Dubai and is one of the wealthiest countries in the Middle East. The medical devices market is …

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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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Global Registration

WebRDC ANVISA 16/2013. Other Global Markets Available On Request. For any manufacturer, overcoming these regulatory hurdles is essential to gain access to new markets and …

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