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Medical Device Regulation

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

Opinion

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

News

Dr Isabell Lang-Zwosta, Dr Knoell Consult, discusses clinical evaluation reports and the challenges and consequences for the medical device industry. more

News

Bryan Austin, general manager of global engineering company Renishaw, writes about how the additive manufacturing industry should handle the European Union’s new Medical Device Regulation (MDR). more

Opinion

With many North American companies looking to do business in the European market, Phil Brown, ABHI director, technical and regulatory, outlines some of the regulatory considerations that need to be taken into account. more

Opinion

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

Opinion

Proactivity and due diligence are the key to success for new MDR roll-out, says Peter Rose, Maetrics more

Opinion

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

News

Engineering and scientific technologies company, Renishaw, will be exhibiting at the Digital Symposium at Swansea University on 29 June as part of its event, “Digital Futures in Health and Wellbeing: can public services survive without them?”. more

News

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

Opinion

Peter Rose, Maetrics takes a look at NHS barcoding and its importance for the medical device sector. more

News

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

News

The Regulatory Affairs Professionals Society (RAPS) is hosting a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices. more

News

European events cover regulatory affairs in the medical device sector more

News

Maetrics reveals key lessons for medical device manufacturers when it comes to preparing for unique device identification. more

News