Greenlight Guru
Greenlight Guru provides a dedicated quality management platform designed specifically to help medical device companies navigate regulatory complexity and bring safe products to market faster.
Hyperproof
Hyperproof is a central compliance operations platform that helps you automate evidence collection, manage multiple frameworks, and streamline audits to stay secure and compliant without the manual effort.
Quick Comparison
| Feature | Greenlight Guru | Hyperproof |
|---|---|---|
| Website | greenlight.guru | hyperproof.io |
| Pricing Model | Custom | Custom |
| Starting Price | Custom Pricing | Custom Pricing |
| FREE Trial | ✘ No free trial | ✘ No free trial |
| Free Plan | ✘ No free plan | ✘ No free plan |
| Product Demo | ✓ Request demo here | ✓ Request demo here |
| Deployment | ||
| Integrations | ||
| Target Users | ||
| Target Industries | ||
| Customer Count | 0 | 0 |
| Founded Year | 2013 | 2018 |
| Headquarters | Indianapolis, USA | Bellevue, USA |
Overview
Greenlight Guru
Greenlight Guru is a specialized quality management platform built exclusively for the medical device industry. You can move away from disconnected paper systems and generic tools to a centralized workspace that aligns with global regulatory standards like ISO 13485 and FDA 21 CFR Part 820. The platform helps you manage the entire product lifecycle, from initial design documentation to post-market surveillance, ensuring your compliance is always audit-ready.
You can accelerate your development timelines by using pre-validated workflows and automated traceability matrices. The software serves medical device startups, scale-ups, and established enterprises looking to reduce risk and improve product quality. By integrating risk management directly into your design process, you can focus more on innovation and less on administrative paperwork.
Hyperproof
Hyperproof is a compliance operations platform designed to take the manual grind out of staying compliant. You can manage all your frameworks—like SOC 2, ISO 27001, and HIPAA—in one central location rather than juggling endless spreadsheets. It automates the tedious process of evidence collection by syncing directly with your existing tech stack, ensuring your controls are always up to date and audit-ready.
You can also identify security gaps in real-time and collaborate with your team on remediation tasks through integrated workflows. Whether you are preparing for your first audit or managing a complex global compliance program, the platform provides the visibility you need to reduce risk and prove your security posture to customers and partners.
Overview
Greenlight Guru Features
- Design Control Management Build your Design History File and maintain a living traceability matrix that updates automatically as your project evolves.
- Risk Management Integration Align your risk workflows with ISO 14971 standards to identify and mitigate hazards throughout the entire product lifecycle.
- Document & Change Control Route documents for electronic signature and manage revisions with automated version control to ensure everyone uses the latest data.
- CAPA & Quality Events Track corrective and preventive actions from start to finish with automated alerts that keep your team on schedule.
- Audit Management Prepare for regulatory inspections with a centralized repository that allows you to pull required documentation in seconds.
- Training Management Assign training tasks to your team and track completion status automatically to maintain a compliant, audit-ready workforce.
Hyperproof Features
- Automated Evidence Collection. Connect your cloud services and security tools to automatically gather evidence and eliminate manual screenshots and uploads.
- Multi-Framework Mapping. Map a single control to multiple regulatory frameworks so you can test once and satisfy many requirements simultaneously.
- Audit Management. Create dedicated spaces for auditors to review evidence securely, reducing back-and-forth emails and speeding up the certification process.
- Risk Register. Identify, track, and mitigate organizational risks by linking them directly to your existing controls and compliance activities.
- Continuous Monitoring. Set up automated alerts to notify you the moment a control fails or evidence becomes stale, ensuring constant compliance.
- Vendor Risk Management. Assess and monitor the security posture of your third-party vendors through automated questionnaires and centralized risk tracking.
Pricing Comparison
Greenlight Guru Pricing
Hyperproof Pricing
Pros & Cons
Greenlight Guru
Pros
- Purpose-built specifically for medical device regulatory requirements
- Automated traceability matrix saves significant manual documentation time
- Excellent customer success team with deep industry expertise
- Intuitive interface compared to traditional enterprise QMS platforms
Cons
- Premium pricing may be high for early-stage startups
- Limited flexibility for workflows outside of medical devices
- Reporting tools can feel restrictive for complex data needs
Hyperproof
Pros
- Automated evidence collection saves hundreds of manual hours
- Intuitive interface makes complex frameworks easy to navigate
- Excellent customer success team provides hands-on implementation support
- Centralized dashboard offers clear visibility into audit progress
Cons
- Initial setup and integration mapping requires significant time
- Reporting customization can be limited for complex needs
- Higher price point compared to basic compliance tools