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[Music] hello everyone im naveen agarwal and im so excited to offer you a free template for a pha a pha stands for preliminary hazard analysis and those of us who have been involved in the medical device industry doing risk management for many many years we understand that doing hazard analysis for a complicated medical device can be challenging especially if you are used to using an fmea or a failure modes and effects analysis method as the only tool for risk analysis of your medical device so as a result i have designed this template based on years of industry experience and knowledge of the challenges and difficulties people face and a solid understanding of the requirements of iso 14971 now the best part of this template is that its not applicable just in the beginning of your design and development process but it grows with you as you develop the product and delivers you at the end a final output complete risk assessment for your risk management file so its all in one place i