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.

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?

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

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