Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.
Identify, mitigate, and prevent potential risks as early as possible.
By integrating the risk management process into your entire quality management system, you can fix issues that expose you to risk when it’s less expensive and time-consuming to do so. Risk management will no longer be a discouraging process with little visibility.
Get a complete and accurate picture of risk across products, processes and teams.
Link risk management to your product development design control traceability matrix, toggle between design and risk with a single click and use risk management together with design controls to mitigate issues before they become problems.
Identify risk acceptability criteria with an easy to use graphical interface that ties into your design control matrix.
Use this criteria and terminology to apply consistent classification of risk across the board. Risk levels are then automatically evaluated based on your criteria and used to populate your risk acceptability matrix -- providing more visibility into risk.
Easily link and connect design controls and documents as risk control measures to mitigate and reduce risks throughout the entire product lifecycle.
Conduct risk analysis evaluation in a traceable system, capturing and recording relevant data throughout the design and development process.
When a project is complete and in production, keep your risk management file up-to-date and living throughout the entire lifecycle by electronically reviewing, signing, and approving documentation with a single source of truth.
