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Risk Management Software

Integrated and Compliant Risk Management

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.

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800+ of the world’s leading MedTech companies trust Greenlight Guru.

Risk

A Risk You Don’t Have To Accept

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.
loopMark

The Only Integrated Risk Management Software Built Specifically for MedTech Companies

Leverage Greenlight Guru’s Risk Management Software to integrate risk throughout the entire product lifecycle and achieve compliance.

Use Risk Management as a Tool

Discover, mitigate, and prevent potential risks as early as possible. 
Integrate and Connect Risk Throughout

Get a complete and accurate picture of risk across products, processes, and teams.
Define Your Risks

Identify risk acceptability criteria with an intuitive graphical interface tied to your design control matrix.
Manage Your Risk Control Processes

Easily link and connect design controls and documents as risk control measures to mitigate and reduce risks throughout the entire product lifecycle.

Integrating Risk Management Doesn’t Need To Be Complex

Designed specifically for the MedTech industry with simplicity and flexibility in mind.

Link Risk Management to Design and Development Activities

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.

Mitigate Risk to Patients

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.

Create Your Risk Acceptability 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.

Maintain a Dynamic, Paperless Risk Management File

Conduct risk analysis evaluation in a traceable system that captures and records relevant data throughout the design and development process.

HubSpot Video
HubSpot Video
HubSpot Video
HubSpot Video
Designed With Your Entire Organization in Mind

Benefits for Teams

Risk touches every part of your medical technology products, so we make sure that our solution does too.

For Product

  • Improve the quality, safety, and effectiveness of your medical technology products
  • Establish a good flow between design controls and risk management
  • Demonstrate a risk-based approach to design with full traceability to related design controls and components
Designed With Your Entire Organization in Mind

Benefits for Teams

Risk touches every part of your medical technology products, so we make sure that our solution does too.

For Quality

  • Ensure your risk management efforts are holistic and documented
  • Maintain compliance with industry standards and requirements
  • Use a risk-based processes to quality

For leaders

  • Ensure there are adequate and appropriate resources for conducting risk management activities
  • Streamline the review of your company’s risk management processes for effectiveness
  • Define and activate your company’s risk management policy and risk acceptability criteria
risk management process total product lifecycle

Stay On Top of Risk

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 Based Approach Graphic-620x380_1

Integrate Risk-based Thinking Into Your Entire Quality Ecosystem

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.

Are You Ready to Experience the Greenlight Guru Difference?

Get a deep dive into our Risk Management Software, ask questions, and see your risk matrix come to life.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities