Get to market faster with eQMS

Greenlight Guru (an Emergo partner) delivers a connected quality ecosystem where every record of your QMS is organized, centralized, and traceable.

Purpose-built platform for medical device companies

Built-in controls that align with 21 CFR Part 820 and ISO 13485:2016.

Flexible review and approval workflows with Part 11 compliant audit trail and e-Signatures.

Fully integrated Design Controls and Risk Management aligned to ISO 14971.

LinkAnything drives full lifecycle traceability.

Zero-effort system validation.

Drive collaboration with task management, comments, and notifications.

Combination medical devices

Bring safer, better medical devices to market faster

Create and update your traceability matrices in minutes, not hours or days. Then easily export records on demand.

Generate design history files without searching for the required documentation.

Save time with Part 11 compliant e-signatures, flexible review and approval workflows, revision control, and more.

Keep your risk management file up to date and avoid costly rework by mitigating potential risks.

Remote usability studies

Advance the success of your devices already on market

Remain compliant and manage risk in the face of ISO and FDA changes.

Identify CAPAs, discover their root causes, resolve them, and report outcomes.

Manage feedback and complaints, escalate when appropriate, and update your risk management file.

Conduct internal audits and always be ready for external audits and inspections.

Ready for the next step?

Ready for the next step?