- Why Us
Controlling critical data and documenting processes can quickly get lost in the weeds at high-growth MedTech companies. What no one tells you is how gaps in these activities impact your commercialization journey. Add in regulatory and compliance requirements to your development goals, and it only gets more challenging. Just a QMS isn’t enough anymore. Your teams need more.
Greenlight Guru is more than your generic QMS software provider. We give you what you need – consistency and flexibility with a seamless, compliant
source of truth.
Leverage our secure, cloud-based document management system to give your team the tools they need to succeed. Review & approve with Part 11 compliant e-signatures. Experience flexible review & approval workflows with full document revision control. Discover what’s possible with real traceability.
Conducting changes within compliance shouldn't be a worry. Leave fretting over how to manage change control processes in the past. No matter how big the change, discover our easy-to-use, formalized change control solution that is efficient, consistent, and intelligent. Adopt formal workflows to manage, analyze, and predict change impact and revisions.
Experience integrated risk management, aligned with ISO 14971:2019. Greenlight Guru reduces the stress of audits and inspections by integrating risk-based thinking into your entire quality ecosystem.
The new era of design control is here. Move forward with multi-level design control software that keeps innovation, quality, and traceability at the forefront. Drive collaboration for design actions, link documents, conduct project reviews, and generate a design history file — all with a single click.
Experience the only product management software built for MedTech. Build and manage items and multi-level BOMs as you design your medical devices. Create a seamless flow from DHF to product development processes, managing critical components of your device master record (DMR) while meeting ISO 13485 requirements.
The only Quality Management Software designed to help MedTech teams deliver innovations to market, streamline compliance, and focus on quality — all in one end-to-end platform. Easily access up to date documents, maintain device traceability, mitigate risk, and build your bill of materials. Get automated quality workflows including Audit, CAPA, Nonconformance, and Complaints management.
Eliminate the disconnect between documentation and people. Manage training with auto-generated records at the individual and document level. Ensure compliance and competency within your organization. Track training and obtain sign-offs — all in a single cloud-based solution.
React. Predict. See how AI and ML can transform your document and change management processes. Experience visual traceability paired with AI-powered change impact analysis. Proactively evaluate quality performance and predict issues before they happen.
With solutions to improve every stage of your product lifecycle and a team excited to support you, achieving MedTech Lifecycle Excellence has never been easier.