Prepare for your next risk management audit with these tips!

We go through many audits in our industry every year. Ace your next risk management system audit with these tips and best practices!


Schedule a free 30-min consultation with me to talk about your specific challenges!


Establishing and operating an effective risk management system for your medical device is not easy.

You must be able to demonstrate effectiveness of your system in an audit or regulatory inspection. It takes a lot of preparation and skill to achieve a successful outcome!

I have more than 10 years of experience in building and operating highly effective, and fully compliant risk management systems in the medical device industry. 

I can help you. 

The best practices and tips I share in this video above are based on my extensive industry experience, both as an auditee and as an auditor. I have also trained internal auditors and lead auditors in auditing management systems according to ISO 19011.

I understand the auditors' perspective and I know what it takes to prepare and manage an audit for a successful outcome. 

With my knowledge and experience with ISO 14971 and ISO 1345 requirements and the Quality System Regulations, I can help you find opportunities for improvement in your system so you can be audit-ready every day.

If you would like to discuss your specific situation in a confidential setting, click the button below to schedule a free 30-min consultation with me.

Let us Talk!

Book a free 30-minute consultation with Dr. Naveen Agarwal today!


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