Greenlight Guru

What Greenlight Guru is

Greenlight Guru provides quality management, product development, and clinical evidence software for medical device companies. Its cloud-based eQMS brings together design, risk, documents, training, suppliers, and quality events. The company describes the system as aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304. Design-control tools support requirements, reviews, verification, validation, design history files, and links between risk controls and requirements.

The Clinical product captures compliant study data and supports studies, adverse-event tracking, randomization, and forms in multiple languages. Pre-built integrations include Jira, GitHub, Google Drive, and Microsoft Office for the web; a REST API can be used for custom connections. Most pre-built integrations operate on a schedule or trigger rather than continuous real-time sync, while customers build and maintain their own API connections. The browser-based service runs on Amazon Web Services and does not require customer hosting. Subscriptions include role-based security, encryption, a dedicated customer success manager, training resources, and support. Pricing is on request, with eQMS packages starting at $12,000 USD per year and Clinical Essentials at $9,000 USD per year. Implementation is priced separately; standard eQMS engagements typically take two to eight weeks, depending on scope.

Who it suits

Greenlight Guru is suited to medical device companies managing quality processes, product development, or clinical evidence. It may fit teams that need connected design controls and quality records, or tools for study data and clinical workflows.

Limits

Clinical Essentials is limited to one ongoing study, up to 10 sites, and a 100GB file vault; eConsent and custom reports or notifications are add-ons. Clinical subscriptions have a 12-month minimum, while eQMS implementation is priced separately.

Getting started

1. Visit the Greenlight Guru website.
2. Access the cloud service through a web browser; customer hosting is not required.
3. Contact Greenlight Guru for pricing and subscription details.
4. Choose between listed eQMS or Clinical offerings based on your needs.
5. Arrange implementation separately if needed.

Verdict

Consider Greenlight Guru if your medical device organization needs quality management, design controls, or clinical evidence tools in a cloud service. The connected eQMS and clinical workflows cover distinct regulated product activities. Look elsewhere if you require continuous real-time pre-built integrations or need pricing without contacting the company.