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[FEATURED] It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program
In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to […]Read More[FEATURED] Cost Of Certification Under IVDR Is Going To Be Huge As Manufacturers Battle Hurdles
There has been no recent impact assessment as to how business will be affected by the text of […]Read More[FEATURED] Regulators Urged To Avoid ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU
EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that […]Read More[FEATURED] It Is A Great Time to Move Within Regulatory – Especially If You Know What To Expect
The demand to fill EU regulatory roles is at its peak and is dictating the very nature of […]Read More[FEATURED] Global Call To Rethink MDR Timing Sees Commission Dig Heels In Further
The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on […]Read More