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Regulation

The MHRA has reiterated guidance on how medical devices will be regulated in the event of a no deal Brexit. Read more

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MedPharmPlast Europe welcomed more than 50 industry experts during a two-day event in Frankfurt. Read more

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The new Europe-based conference plans to build on The Regulatory Affairs Professionals Society’s (RAPS) track record of successful events at a time where there are many changes within the European regulatory environment. Read more

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The entire medical technology value chain will be represented at the Exhibition Centre Nuremberg for the international MedtecLive exhibition and the MedTech Summit Congress from 21-23 May. Read more

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Manufacturers need to set a clear roadmap to compliant clinical evaluation reports, says David Egbosimba, solutions delivery manager, Maetrics. Read more

Opinion

A historical lack of transparency in the UK’s medical devices industry has led to debilitating consequences for patients, the government admitted this week. Read more

News

Group Editor Dave Gray shares his predictions for 2019 on how regulation and technology will affect the industry. Read more

Opinion

Maik Endler, Knoell Germany, examines the challenges for start-ups gaining medical device approval. Read more

Opinion

Paul Bulteel, partner at life sciences executive search firm the RSA Group, discusses why the medtech industry needs new talent to help navigate regulatory changes and enable market access for medical devices. Read more

Opinion

Exhibitors attending the Med-Tech Innovation Expo share their views on Brexit, sector expectations, key initiatives and more in this insightful interview into the medtech industry. Read more

Opinion

The FDA has released new guidelines to aid medical device regulation and assess the effectiveness of cardiovascular products. Read more

News

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR) Read more

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European events cover regulatory affairs in the medical device sector Read more

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With MasterControl, Megadyne confidently demonstrates to regulatory bodies throughout the world how it complies with record retention, documentation and change control. Read more

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Two proposed regulations on medical devices and in vitro diagnostic medical devices (IVDs) will be adopted by the European Commission by the end of May. Read more

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IDC’s MD, Stephen Knowles, advises about the regulatory requirements for connected medical devices. Read more

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Maetrics reveals how to navigate post-market surveillance requirements in free whitepaper Read more

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Regulators are heightening post-market surveillance requirements to ensure medical device safety issues are identified as early as possible. Maetrics has written a whitepaper on how to navigate these requirements Read more

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The latest edition of ISO 13485, the quality management systems standard for the medical device industry, has been published Read more

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European Union regulations that date back to the 1900’s are currently under reform. Read more

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