Let's Help You Succeed in Risk Management

Build knowledge, learn skills and gain expertise in risk management to grow your career to new heights in the medical device industry



Where Would You Like To Start?

Build Knowledge

Establish a solid foundation of knowledge in risk management by mastering the fundamentals.


Learn Skills

Develop a deep understanding of requirements, tools and techniques to help execute risk management activities and make a significant impact.


Gain Expertise

Build world-class competence through live training and personalized coaching to help establish and operate highly effective risk management systems.


Hazard Analysis Made Easy

ISO 14971 requires analysis of risk, which involves identification of hazards and hazardous situations. 
But it proves to be challenging to actually do it right.
This is because the terminology is confusing and we are not using the right tools. 

Join me in this free webinar where I will help you understand key terms and relationships and share an easy template to do your hazard analysis.  

Sign up Here


Level Up Your Risk Management Expertise

Stay ahead of the curve by learning about new tips and techniques through insightful articles on our comprehensive blog.

Case study - When Miscalculating Risk Leads to a Warning Letter

ISO 14971 Fundamentals: Characteristics related to safety

ISO 14971 Fundamentals: Reasonably Foreseeable Misuse



I'm Naveen Agarwal

As a Product Quality Manager in my last role at a multi-billion dollar medical device manufacturer, I was asked to establish a post-market safety surveillance process from the ground up and integrate it with the overall risk management system. 

This was more than 10 years ago. 

I did not know anything about risk management and post-market surveillance at that time. It was confused and terrified!

It was a steep learning curve for me and it took me a while to fully understand the basic terms and key concepts, before I could fully understand the requirements of ISO  14971.

But my hard work paid off. I was able to not only create a compliant process, but also lead it in operation for a period of 2 years. This experience helped me to fully understand the practical, day-to-day challenges in the practice of risk management. 

Now I use my own personal struggle and success to help people just like you build a world-class expertise in risk management of medical devices from the ground up. Whether you are just starting out, or looking to deepen your current knowledge, I can help you achieve excellence in risk management through my world-class online  courses and personalized coaching programs. 

Risk management is a challenging, but highly rewarding field. It is a highly transferrable skill that can help you take your  career to new heights in the medical industry. 

Wishing you success ahead!


"Highly recommend these coaching sessions on Risk management by Naveen. The sessions were planned very well and, Naveen, with his vast experience in risk management, was able to provide expert feedback on how various risk management approaches could work. ."

- Ankit B.
Risk Manager

"In the other risk management trainings, the approach was very focused on going through the requirements in theory, I liked this one because it was very practical and helped us with an approach on how to achieve compliance to the standard"

- Gabriela C
Senior Manager, Quality Systems

"The most useful part was to work with the case study and opportunity to ask questions. I feel extremely confident that I can begin applying this knowledge immediately."

- Frantisek L.
Design Quality Assurance

Online Courses, Live Training and Personalized Coaching

Whether you are just starting out, or looking to deepen your knowledge, these world-class learning and development opportunities will help you achieve your goals.

The Basics

Learn key terms and fundamental concepts in risk management of medical device.

(USD $99)


Self-Paced ISO 14971 Certification

Learn at your own pace with this comprehensive on-demand course and get certified in ISO 14971. As a bonus, get a free 1:1 personalized coaching session!

(USD $399) 


ISO 14917 Live Certification Training

Get certified in ISO 14971 in this live training course with just 2h each week for a total of 5 weeks.

(USD $899)


Risk Management File Made Easy

Learn about ISO 14971 requirements for risk management file documentation in this mini-course. As a bonus, get tips for preparing for your next risk management audit!

(Pay what you want!)



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