ISO 14971 is the primary ISO rule that regulates risk management for medical equipment. ISO 14971 is a worldwide standard that offers a framework for controlling the risks connected to medical devices at every stage of their life cycle, from conception and design to production, distribution, and usage. The Risk Management Process, Risk Assessment, Risk Control and Mitigation, and Risk Management File are some of the essential components and standards of ISO 14971 for a medical device company. It is essential to incorporate risk management into the production process and establish procedures for overseeing and resolving post-trade concerns and new discoveries that could influence risk evaluations.