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Design Controls, Design and Development under FDA QMSR
Eoin Philip Kelly
February 04th, 2026 - Eoin Philip Kelly

Design Controls, Design and Development under FDA QMSR

Michelle discusses Design Controls, ISO 13485 Design and Development and what endures under the FDA’s QMSR in effect from February 2026.

medical devices fda regulations iso 13485
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?

medtech medical devices fda regulations iso 13485