medical devices

In a recent poll, the majority wanted Michelle to discuss Training and Competence, Clause 6.2 of ISO 13485. In this blog, she shares her thoughts.

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

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 it true or false that a medical device organization that uses spreadsheets is only required to validate spreadsheets that contain calculations?