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European Medical Device Regulation (MDR)

The labelling of medical devices can be a complex process. As EU MDR implementation heads closes, Mark Cusworth, Prisym ID asks - will your label comply? more

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With Brexit looming, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS) discusses how medical device companies should respond to the EU's new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). more

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A global support programme to help medtech start-ups bring new devices to market faster has been announced by software vender MEDEI. more

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Albis Plastic is expanding its product portfolio to include custom compounds for healthcare applications, the company has announced. more

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Dave Gray, editor of Med-Tech Innovation News, talks to some of the world-class speakers giving presentations during this year's Med-Tech Innovation Expo. more

Expo News

The honorary sponsor of MT-Connect has released new guidance and recommendations on medical device regulations (MDR). more

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In advance of Med-Tech Innovation Expo, Dave Gray, editor at Med-Tech Innovation News spoke with a handful of speakers about the challenges of working in the sector, plus the many opportunities. more

Expo News

Mark Cusworth, PRISYM ID, examines EU Medical Device Regulation and its implications on labeling – and looks ahead to a Christmas future that could become a nightmare unless companies act now. more

Features

Sheena Linehan, patent attorney at IP law firm Potter Clarkson talks about the new EU medical devices regulations and why IP strategy needs refreshing. more

The BSI’s UK & Ireland Medical Devices Regulatory Seminars in November are for all medical device manufacturers, regulatory affairs and quality assurance staff. more

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Global public health and safety organisation NSF International recently completed the acquisition of Prosystem, a German medical device consulting firm specialising in regulatory affairs and clinical evaluation. more

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The British Standards Institution (BSI) tells Med-Tech Innovation why it developed Compliance Navigator – a workflow tool that takes the leg-work out of managing medical compliance. more

Features

Here’s ten things you really need to know about the new European Medical Device Regulation. more

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An introductory guide has been made available by the Medicine and Healthcare products Regulatory Agency (MHRA), so manufacturers are aware of requirements under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). more

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Now in its 15th year, the Medtec Ireland trade show will be exploring recent advancements in medical devices. more

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Quality provider InfinityQS has argued that the medical device industry must develop a common language within its data systems to ensure full legal compliance and internal traceability. more

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Paul Brooks, Regulatory Affairs Professionals Society (RAPS), discusses the impact of European Medical Device Regulation on currently marketed medical devices and offers guidance for manufacturers. more

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Maetrics reveals the practical implications for medical device manufacturers and how to address them as the new MDR comes into force. more

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