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Regulation

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. 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. more

Opinion

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

News

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

News

European events cover regulatory affairs in the medical device sector more

News

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

News

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. more

News

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

News

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

News

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 more

News

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

News

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

News

Shedding light: Brett Rowland and Magdalena Gray, Eversheds LLP, outline the changes to the law on medical devices in the EU and what this will mean for manufacturers. more

, News

Talking point: Mark Hassenplug, president and ceo of global life sciences compliance consulting firm, Maetrics, was selected to give a keynote address on the medical device industry and the changing global regulatory landscape it faces. more

News

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Source: Messe Düsseldorf.

Bill Carteaux, President and CEO of SPI: The Plastics Industry Trade Association—based in Washington, DC, USA—writes about how the association provides legislative and regulatory advocacy on behalf of the plastics industry. more

Opinion

Leaders of the chemicals industry are travelling to London today for a summit chaired by Cabinet Minister Ken Clarke to discuss the proposed free trade agreement between the EU and the US. more

News

MasterControl, a USA-based provider of quality management software solutions, has announced the establishment of a partnership with the globally respected International Quality Consulting (IQC) Group. more

Technology

Eucomed welcomes the results of a plenary session which has endorsed essential measures that strengthen patient safety and which has improved the approaches on the approval system. But questions remain on re-processing of medical devices. more

News

RoHS sets out limits for hazardous substances like lead and mercury in electric and electronic devices. In July 2014, medical devices will be subject to these limits. And in July 2016, all in vitro diagnostic medical devices must be compliant. more

Opinion

Eucomed has voiced strong concern over a new scrutiny procedure, which it says will hamper innovation while resulting in patients waiting longer for life saving medical technologies without improving safety. more

News