Regulation
Seeking approval: The challenges start-ups face gaining medical device approval
Maik Endler, Knoell Germany, examines the challenges for start-ups gaining medical device approval. Read more
New talent needed for a new era of market access in the medtech industry
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
Why Brexit, regulations and investment are vital for UK medtech
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
New FDA guidance aims to aid medical device development
The FDA has released new guidelines to aid medical device regulation and assess the effectiveness of cardiovascular products. Read more
Ready, steady, go: Tightened EU medical device regulations are here
The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR) Read more
Events examine EU regulations and directives
European events cover regulatory affairs in the medical device sector Read more
Consolidation helps Megadyne successfully comply with multiple regulatory agencies
With MasterControl, Megadyne confidently demonstrates to regulatory bodies throughout the world how it complies with record retention, documentation and change control. Read more
Medical devices regulations to be adopted by Europe in May
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
Playing by the rules: Regulatory requirements for connected medical devices
IDC’s MD, Stephen Knowles, advises about the regulatory requirements for connected medical devices. Read more
Medical device industry braced for spotlight on post-market surveillance
Maetrics reveals how to navigate post-market surveillance requirements in free whitepaper Read more
Regulators crack down on medical device sector
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
New standards for medical device quality management
The latest edition of ISO 13485, the quality management systems standard for the medical device industry, has been published Read more
New framework for European medical device regulations
European Union regulations that date back to the 1900’s are currently under reform. Read more
EU regulation for medical devices – what does it mean?
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. Read more
Maetrics ceo addresses issues of regulation at Medtech Europe
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. Read more
Source: Messe Düsseldorf.
SPI Advocacy Addresses Critical Issues for US Plastics Industry
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. Read more
Chemical Industry Leaders Attend US-EU Trade Summit
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. Read more
Mastercontrol Partners with Germany's International Quality Consulting
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. Read more
European Medical Device Industries Welcome European Parliament Improvements on Proposed Regulations
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. Read more
Understanding RoHS: Implications for Medical Device Manufacturers and Suppliers, by C Alex Wensley, PE
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. Read more