Greenlight Guru reduces the stress of audits and inspections by integrating risk-based thinking into your entire quality ecosystem, keeping you in compliance with the risk management standard ISO 14971:2019 and risk-based requirements of ISO 13485:2016.
Risk management can be a difficult process. Regulations like ISO 14971:2019 make it easier for MedTech companies. Too many companies find themselves falling short and wasting time on connecting their design controls with risk management or ensuring that risk management is a living process throughout the entire product lifecycle. For all these reasons, we developed Greenlight Guru.
Designed specifically for the MedTech industry with simplicity and flexibility in mind.
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.
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.
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.
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.
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.
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.
Conduct risk analysis evaluation in a traceable system that captures and records relevant data throughout the design and development process.
Conduct risk analysis evaluation in a traceable system that captures and records relevant data throughout the design and development process.
Use a risk-based approach to define and document your processes and product risks. Strong risk management involves a series of tools that, when used properly, will drastically improve the quality, safety, and effectiveness of your medical technology products.
Risk management is a total product lifecycle process. When a project is complete and in production, keep your risk management file up-to-date throughout the entire lifecycle by electronically reviewing, signing, and approving documentation with a single source of truth.