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?

Comply Guru proudly sponsored Global Access 2024 which is ‘s largest conference for Quality and Regulatory Affairs Professionals in Medical Devices.

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

On 30th October 2023, IRCA formally certified Comply Guru’s latest Blended Learning offering, a Combined ISO 14001 and ISO 45001 Lead Auditor Training (No. 2677) that is a hybrid of eLearning and Live Workshops.

Comply Guru is excited to announce a new strategic partnership with Clinius Oy in Finland, a pioneer in clinical device trials who are a device CRO specializing in clinical device studies, product documentation and quality systems for the Medical Device Industry.

Today I am proud to announce our new & improved website for , UK and the U.S is now live! I have personally managed this project as I sought to make various improvements across the entire website.

While the EU Medical Device Regulation (MDR) brings numerous improvements, it also poses several challenges that need to be addressed. In this blog, I discuss five of the challenges under the European Medical Device Regulation.

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.