iso 13485

When we last left off at Spreadsheet Validation (part 1), we had covered the various standard and regulatory requirements that apply to spreadsheet validation and the types of spreadsheets that require validation. Now, as promised, part 2. Spreadsheet Validation under ISO 13485 Starting with determining criticality classification, we will also examine the relationship that exists […]

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?

Join us on Tuesday, November 28th for a free Webinar on Improving Internal Audit Effectiveness with John Collins from 3-4pm GMT.

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.