fda regulations

June 06th, 2025 - Eoin Philip Kelly

Free Essentials eLearning Launched

It is now possible to eLearn for FREE with Comply Guru following the launch of a portfolio of Essentials courses on widely adopted International Standards and Medical Device Regulations.

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As per ISO 13485, is Spreadsheet Validation required?

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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