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First Expert Panel Opinion Offers Valuable Learning Opportunities

 
• By Amanda Maxwell

BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.

Training and development business education concept with a hand holding a group of gears transferring the wheels to a human head made of cogs as a symbol of acquiring the tools for career learning. - Illustration

Expert opinions should raise the bar in the EU for the clinical review of high-risk devices by notified bodies, in what Gary Slack, senior vice president of the notified body at BSI Regulatory Services (Medical Devices), calls a much-needed improvement.

This is because the level of clinical scrutiny of these products by notified bodies has been “variable” in the past,...

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EU Authorities Unite In Call For Urgent Overhaul Of Medtech Regulations

 
• By Amanda Maxwell

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European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

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More from Geography

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 
• By Eileen Francis

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.

PFA Market Surges As UK NICE Opens Doors And US FDA Approves Boston, J&J Incremental Innovations

 
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• By Brian Bossetta

Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.