Description of the Topic:
Medical Device Companies are using different tools to identify and manage the risks but some companies lack the over all process to connect the dots. This gap has resulted in several field failures and significant recalls of the products due to inappropriate prioritization of risks involved. ISO 14971 provides a comprehensive model to not only identify the risk, but also to prioritize and mitigate the risks to as low as reasonably possible. The scope includes the entire product realization process including the after life disposal of the devices. This presentation will discuss the key elements of the process and how to connect different activities to better understand the product and process risk and risk mitigation.
Medical Device Companies are using different tools to identify and manage the risks but some companies lack the over all process to connect the dots. This gap has resulted in several field failures and significant recalls of the products due to inappropriate prioritization of risks involved. ISO 14971 provides a comprehensive model to not only identify the risk, but also to prioritize and mitigate the risks to as low as reasonably possible. The scope includes the entire product realization process including the after life disposal of the devices. This presentation will discuss the key elements of the process and how to connect different activities to better understand the product and process risk and risk mitigation.
