Greenlight Guru provides comprehensive software solutions tailored for the entire medical device lifecycle, combining intuitive tools with deep industry expertise. It helps medical device companies achieve efficiency, maintain compliance, and stay audit-ready at all times.
Key Features:
- Design and Development: Digitally manage your Design History File (DHF) with built-in traceability between design inputs, outputs, verifications, and product risk controls.
- Compliance and Risk Management: Track and manage operational risk across your Quality Management System (QMS), covering regulatory requirements, audit readiness, and CAPA trends.
- Documents and Training Management: Centralize control over documents, changes, and training with automated routing, comprehensive audit trails, and role-based access.
- Quality Processes and Events: Log, track, and resolve quality events within a connected system that seamlessly links Corrective and Preventive Actions (CAPAs), training, and documentation.
- Clinical Data Management: Capture compliant, audit-ready clinical data across all phases of your study, from first-in-human trials to post-market surveillance.
Use Cases:
- Quality Management: Streamline compliance, deliver innovations, and maintain a strong focus on quality throughout product development and post-market activities.
- Clinical Data Collection (EDC): Utilize a leading clinical trial data collection toolbox specifically designed for MedTech, featuring no-code setup for various study types.
Why Greenlight Guru?
- Made for Medical Devices: Software built specifically for the unique needs of the medical device industry, supported by experienced experts.
- Guided Implementation: Achieve rapid time-to-value, often in weeks, through a personalized implementation plan.
- Built for Growth: Designed to support companies from developing their first device to managing extensive product portfolios, ensuring scalability and future readiness.
