Let's talk about risk management so we can understand it better and do it right. I'm Naveen Agarwal. Nice to meet you. This was more than 10 years ago.
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. 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!