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Why does CAPA get a bad rap in the Medical Device Industry?
Eoin Philip Kelly
December 04th, 2024 - Eoin Philip Kelly

Why does CAPA get a bad rap in the Medical Device Industry?

Michelle Keane discusses CAPA in Medical Devices including potential reasons organizations struggle and the FDA raise so many findings in this area.

iso 13485 medtech medical devices capa
As per ISO 13485, is Spreadsheet Validation required?
Eoin Philip Kelly
November 25th, 2024 - Eoin Philip Kelly

As per ISO 13485, is Spreadsheet Validation required?

As per ISO 13485, is it true or false that a medical device organization that uses spreadsheets is only required to validate spreadsheets that contain calculations?

fda regulations medical devices iso 13485 medtech
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