Building Software as a Medical Device?
Platform
Medical Device Expertise
AI, Data, Intelligence
Learning, Templates. Training
The Greenlight Guru Platform
Solutions built for medical device teams to move faster, stay compliant, and grow with confidence.
Quality Management
Manage quality events, training, and documentation in one place.
Document Management
Control documents, training, and change with traceability.
Quality Events
Track CAPAs, audits, and NCs with audit-ready records.
Suppliers & Operations
Qualify suppliers and manage parts with visibility.
Product Development
Connect design, risk, and AI-powered traceability as you build.
Requirements Management
Link needs, requirements, and verification to design controls.
Software Release Management
Automate traceability from dev tools for faster releases.
Risk Management
Assess ISO 14971 risk as requirements and tests evolve.
Clinical Evidence
Oversee studies with connected data, documents, and workflows.
Clinical Trials
Capture compliant clinical data with a validated medical EDC.
PMCF
Plan and manage PMCF aligned to EU MDR expectations.
ePRO/eCOA
Collect clinical outcome data in-person or remotely on any device.
Built with regulatory insight to help medtech teams move faster with confidence.
Find issues faster and make smarter decisions with less manual work.
Tools and resources that help teams implement quickly and meet requirements.
