Comply Guru Blog

medical devices

Practicalities of performing Spreadsheet Validation
Eoin Philip Kelly
December 10th, 2024 - Eoin Philip Kelly

Practicalities of performing Spreadsheet Validation

This insightful blog looks at the practicalities of performing a spreadsheet validation under ISO 13485.

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.

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?

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