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Preparing a FDA 510(k) submission - What to Know in 2024

Preparing a FDA 510(k) submission - What to Know in 2024

Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..

Date : 29th October 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Overview: In the world of medical device development, the US FDA places a high priority on ri..

Date : 14th August 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 75 Mins

Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304

Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304

Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..

Date : 28th May 2024

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

Excel Spreadsheet in FDA Regulated Environment in 2023

Excel Spreadsheet in FDA Regulated Environment in 2023

Overview:The use of Excel in FDA-regulated environments goes beyond typical data organization and ..

Date : 27th July 2023

Time : This Event is Over

Duration : 90 Mins

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