Global Certificate in ISO 13485: Risk Management
-- ViewingNowThe Global Certificate in ISO 13485: Risk Management is a crucial course for professionals seeking to excel in the medical device industry. This certificate program focuses on risk management strategies that align with ISO 13485, an internationally recognized standard for quality management systems in medical device manufacturing.
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โข Introduction to ISO 13485 & Risk Management: Understanding the importance of risk management in medical devices and how ISO 13485 supports it.
โข Risk Management Process: Identifying and assessing risks, implementing risk controls, and monitoring the effectiveness of risk management activities.
โข Risk Management Tools: Utilizing tools such as FMEA, Hazard Analysis, and Risk Matrix to support risk management activities.
โข Risk Management in Design and Development: Integrating risk management into the design and development process to ensure that risks are identified and managed early.
โข Risk Management in Production, Installation, and Servicing: Ensuring that risks are managed throughout the production, installation, and servicing stages of the medical device lifecycle.
โข Risk Management in Purchasing: Managing risks associated with the selection and use of suppliers and purchased materials.
โข Risk Management in Transportation and Storage: Identifying and managing risks associated with transportation and storage of medical devices.
โข Risk Management in Product Realization and Release: Ensuring that risks are managed throughout the product realization process, from design and development to final release.
โข Risk Management in Post-Market Surveillance: Utilizing post-market surveillance data to identify and manage risks associated with medical devices in the market.
โข Continual Improvement of Risk Management: Implementing a plan for continual improvement of risk management activities, including periodic reviews and updates to the risk management process.
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