Qualifications
Greenlight Guru is the only product development and quality solution with the latest FDA and ISO best practices specific to medical device companies built into every feature.
- 21 CFR Part 11 Compliant
- Workflows aligned to FDA and ISO standards for medical device pre-defined processes
- FDA 21 CFR Part 820
- ISO 13485:2016
- ISO 14971:2019
Greenlight Guru has been recognized as the Leader in Quality Management Software Solutions by G2 Crowd for ten consecutive quarters, along with being awarded:
- Medical QMS Leader
- Users Most Likely to Recommend
- Best Support
- Best Relationship
Services
Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market.
The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance and provides a single source of truth by connecting the management of all product development, regulatory and quality processes from documentation and design controls to submission and ongoing compliance.
- Automate design control and risk activities
- Follow FDA & ISO best practices
- Achieve end-to-end traceability
- Enhance team collaboration
- Streamline submission and device clearance
Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensuring successful product launches and in-market success of innovative, life-changing devices.
