Cockpit Crew Blog

Michelle's Moment: New Revision for ISO 62366-1 Application of Usability Engineering

Pulse Check: New Revision for ISO 62366-1 Application of Usability Engineering to Medical Devices

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Michelle's Moment: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

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Michelle's Moment: FDA Provides Clarification on "Add-to-File" Process

Pulse Check: FDA Provides Clarification on the "Add-to-File" Process

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Michelle's Moment: Tell Me What You Want to Know!

May brought many exciting opportunities for me to travel to various conferences to get up-to-date information directly from industry experts and even straight from the FDA. With the additional travel, I did not get to cover a couple of the significant guidances released in May.

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Michelle's Moment: New FDA Draft Guidance Patient Preference

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Michelle's Moment: Expedited Access for Premarket Approval and De Novo Medical Devices

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Michelle's Moment: FDA Draft Guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S.

Pulse Check: FDA Draft Guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S.

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Michelle's Moment: CDRH Seeks Participants for the Electronic Submission for Home Use Device Labeling Pilot Program

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Michelle's Moment: Regulatory Guidance - Safety Considerations to Mitigate the Risks of Misconnection with Small-bore Connectors

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