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Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions

Jan 18, 2023 | News

Human Factors Engineering is a crucial part of ensuring the safety and effectiveness of medical devices. Human factors testing is valuable when designing device/user interfaces. To help manufacturers understand the extent of human factors (HF) information required in...

‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)

Nov 8, 2022 | News

When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group. The MDCG’s plan,...

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