1,000+ of the world’s leading MedTech companies trust Greenlight Guru.
Conducting Changes Within Compliance Shouldn’t Be a Worry
The FDA, EU MDR, and ISO 13485 all require the documentation and management of change be done to standard. That’s why it’s critical to have a QMS that supports you in achieving regulatory compliance while you are developing your products and processes. We understand it’s a challenge to keep change both streamlined for efficiency and thorough enough to meet all the requirements.
Consistent & Efficient Change Management
Greenlight Guru's Change Management system enables both small and large scale change as you need it.
Eliminate data silos. Manage change reviews and approvals using the same process every time.
Connect changes across different design and quality documentation.
Obtain CE markings, gain ISO 13485 approvals, and stay compliant under FDA and EU MDR guidelines.
Collaborate Across Teams
Route and review across all your teams—document control, quality, product development, manufacturing, and operations.
Catch the Impact of Change
Designed specifically for the MedTech industry with simplicity and flexibility in mind.