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EU | Substantial modification Documents for Performance Studies under Regulation (EU) 2017/746

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EU | Substantial modification Documents for Performance Studies under Regulation (EU) 2017/7462023-01-06T12:30:40+00:00

EU | Performance Study Application/Notification Documents Under Regulation (EU) 2017/746

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EU | Performance Study Application/Notification Documents Under Regulation (EU) 2017/7462023-01-06T12:23:40+00:00

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

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USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions2022-12-17T09:39:22+00:00

USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order

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USA | FDA Publishes Final Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order2022-11-14T16:49:14+00:00
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