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Compliance Corner: FDA Investigator Lists 7 Common Human Factors Problems, Says Usability Is 'Overlooked'

 
• By Shawn M. Schmitt

Longtime agency investigator Laureen Geniusz reveals seven usability issues that agency investigators regularly see when inspecting medical device manufacturing facilities – troubles that could jeopardize patient safety. Her chief concern? "Human factors seems to be overlooked and not fully understood," Geniusz says.

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Laureen Geniusz is concerned about human factors work at medical device firms.

Specifically, the longtime US FDA investigator says some device-makers simply don't think about what might happen once a product finds...

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More from Regulation

Roberts’ Departure At NICE Sparks Hunt For New CEO

 
• By Ashley Yeo

Healthtechs are reflecting on the resignation of Sam Roberts as chief executive of NICE and how medtech assessment program changes underway at the England and Wales HTA body might be impacted.

Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 
• By Brian Bossetta

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

More from Policy & Regulation

How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 
• By Amanda Maxwell

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.

Device User Fees Up About 7% For FY2026

 
• By Elizabeth Orr

The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.