Keep your post-market medical devices safe and compliant in any country
Use the only modern eQMS designed exclusively for medical device companies to stay ahead of FDA and ISO changes while growing your business.
Our eQMS Software helps post-market medical device companies like yours...
Have Instant End-to-End Traceability
Forget the paper and spreadsheet-based traceability matrices. Greenlight.guru automates traceability and makes it easy to trace a CAPA all the way back to your design controls.
Automate Quality Processes
Don’t wait for QA to catch issues when they’re more expensive and difficult to fix. Avoid post-market catastrophes when quality and risk management are built into every design and development process.
Follow FDA/ISO Best Practices
This is the only eQMS that has FDA and ISO best practices specific to medical device companies built into every feature. You’ll know your work is always aligned with the latest regulations in any country you operate within.
Streamline Team Communication
Stop wasting time on unnecessary meetings, long email threads, and managing communication across apps. In greenlight.guru, collaboration and communication happens where your team works.
Customer Complaint Management
Streamline a customer feedback and complaint processes that aligns with FDA regulations.
Quickly determine whether feedback requires immediate action or the issuing of a CAPA.
Ensure your customer complaint processes are compliant and easily audited by regulatory bodies in any country.
Optimize customer feedback management and oversight for faster response times.
Conduct internal and external audits, automatically route findings based on risk, and easily share results.
Manage tasks, follow ups, communications, and any actions that result from audit findings.
Automatically escalate high-risk findings for investigation and monitor low-risk findings for recurrence.
Create and share final audit summaries internally and externally with a single click.
Focus on your products and growth by taking the headaches out of managing post-market devices.