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[FEATURED] CE Featured Article BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow
There is not much demand currently for testing against the EU’s Medical Devices Regulation (MDR). But demand for […]Read More[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] 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