iso 13485

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.

One of the most common questions I am asked relates to whether internal auditor or lead auditor training is the right choice. The answer is it depends on several factors. Let’s discuss.

Let’s talk about Blended Learning. In 2019, Comply Guru set out to create a new approach to conventional Auditor Training, launching it’s first CQI & IRCA Accredited Blended ISO 9001 Internal Auditor Training Course (No. 2149) in March of the same year.