Medical Device QMS & eQMS Software | Greenlight Guru

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What is medical device quality management software?

Medical device quality management software, often called an eQMS, is a cloud-based quality management system that brings document control, training, supplier management, internal audits, CAPA, complaints, risk files, design controls, and quality data into one connected system for medical device manufacturers.

For medtech teams, it preserves traceability across product development, regulatory submissions, commercialization, and post-market activity. The Greenlight Guru Platform is purpose-built to keep those records audit-ready as companies scale.

Be confident in your compliance.

6+ months

Typical delay in commercialization due to gaps in traceability

When Canterbury Scientific needed a QMS to keep them compliant and audit-ready in both the US and the EU, they switched from paper to Greenlight Guru.

“What used to take us six weeks takes a much shorter period of time. In terms of cost, what we pay to have Greenlight Guru is repaid in efficiency.”

Clive Seymour,

CEO, Canterbury Scientific

Built for medtech teams from first regulated design through scale-up

Paper, spreadsheets, and generic QMS tools create gaps in document control, change management, and traceability that become harder to manage as products, suppliers, users, and audits grow. Greenlight Guru gives medical device startups, pre-market teams, and growing manufacturers one purpose-built system that supports first submissions, ISO 13485 audits, design transfer, and multi-product scale.

No more compliance nightmares

Automate routine quality management workflows so your team can keep compliance moving and stay aligned with key compliance standards.

Quality and Product united

One system for both teams means no data silos, less compliance risk, and better collaboration.

Medtech-specific workflows

Built-in alignment with FDA, ISO 13485, ISO 14971, and other applicable compliance standards keeps your team compliant without slowing you down.

Unbeatable medtech support

Medical device industry experts are always on hand to support and guide your team at every step.

What does Greenlight Guru’s quality management software include?

Document Control

Change Management

Training Management

Supplier Management

Quality Events

Parts and Inventory /BOM

Risk Management

CAPA & Nonconformance

Audit Management

Design Controls & DDF

Document control software for medical device teams

Track every document in a single, validated system.

Poor document management leads to mistakes and audit findings. The platform makes reviews, approvals, and version control simple. The QMS software centralizes controlled documents in a validated eQMS software platform, making reviews, approvals, version control, and audit trails easier to manage as part of a connected quality management system.

Track every change, automatically.

From version history to approvals to downstream training, every action is logged and linked without gaps or manual effort.

Work in tools your team already uses

Create, edit, and co-author controlled documents in Google Docs and Microsoft Office for Web, while maintaining full document control, versioning, and approvals within Greenlight Guru.

Save time with smart workflows

Edit documents in-line, schedule periodic reviews, and keep approvals moving with built-in reminders that eliminate follow-up.

Change management with full traceability

Control every update without slowing your team down.

Greenlight Guru makes updates visible, reviewable, and fully traceable from the moment a change is requested through approval and implementation. Every change is evaluated for risk, training, and downstream impact with built-in prompts that prevent missed steps.

Catch issues before they spread.

Connected records show what’s affected and what needs attention, from SOPs to specs to training requirements.

Save time with guided routing.

Route updates through the right reviewers, compare old and new versions side by side, and track every approval in one place.

Training management connected to document control

Keep your team trained without chasing them down.

Our integrated training management solution lets you easily assign and track training to ensure your team is up-to-date on current procedures, quality processes, and required compliance standards.

Assign training for anything, no workarounds required

Tie training to document updates with built-in policies for roles, teams, and events like new hires, or assign standalone training as needed.

See exactly where things stand

Track completions by person, team, or document so you always know who’s trained, what’s overdue, and what still needs to happen.

Save hours with background compliance

The platform routes assignments, logs completions, and handles validation behind the scenes.

Supplier management software that scales with your business

Stay in control as your supplier list scales.

Greenlight Guru applies the right oversight automatically, so your supply chain stays clean and compliant.

Enforce controls by risk level.

Set supplier types and risk once. The system auto-applies required docs, approvals, and monitoring.

Keep every supplier compliant.

New entries follow your defined process automatically. No extra QA policing required.

Save time with built-in oversight

Export reports, automate reminders, and skip the manual tracking during audits.

Supplier evaluation tied to risk and quality records

Evaluate suppliers by risk, documentation, qualification status, audit history, quality events, and performance. Link supplier issues to CAPA, nonconformance, parts, BOMs, and audit records as the business scales.

Quality event, corrective and preventive actions, and CAPA management with root cause analysis

Close issues faster with a connected system.

Manage all your quality events in one place, including CAPAs, complaints, and other quality records, so you can close them out faster.

Configure workflows to fit your process.

Start from best-practice templates or fully tailor event types, stages, questions, and required fields as your team evolves. Use connected workflows to evaluate each customer complaint, link it to affected products or documents, and determine whether it requires escalation, CAPA, or additional investigation.

Link issues to what matters

Every event ties directly to affected products, documents, and changes, giving you a complete quality record without digging.

Route and sign off without delays

Assign tasks, route reviews in parallel or sequence, and sign digitally with 21 CFR Part 11-compliant approvals built into the flow.

Customer complaint and post-market quality management

Capture every customer complaint, evaluate it for reportability, and link it to affected products, risk controls, and CAPAs, so post-market surveillance and vigilance reporting stay connected to the rest of your QMS.

Part, revision, and BOM management for product quality

Track every part and revision

Track every part to ensure you have a complete, connected view of your product from end to end.

Centralize your parts

Define part types and use automated, custom IDs to create a single source of truth for all your parts.

Control every change

Automatically manage part revisions through a built-in change control workflow, with full version tracking and approval history.

Build your BOM

Organize parts into hierarchies to reflect your Bill of Materials (BOM) and instantly see where a part is used across all products.

Risk management, quality planning, and quality management in one connected QMS

Maintain a dynamic, paperless Risk Management File

Streamline risk reviews and trace documentation throughout your design and development process to easily maintain an audit-ready Risk Management File.

Stay compliant with ISO 14971:2019.

Be confident in your compliance with software designed in accordance with the latest standard in medical device risk management and connected to the broader quality processes in your QMS.

Unite risk management and design controls

Integrate your risk management and design processes by linking design controls and documents as risk control measures.

Build your risk acceptability matrix

Ensure consistent classification of risk across the risk project and evaluate risk levels based on your set criteria.

Support risk-based thinking from planning to production

Support risk-based quality planning: Keep the records that support FMEA, Control Plans, SPC, APQP, supplier controls, approvals, changes, CAPAs, and risk management connected so teams can see how manufacturing and product decisions affect quality and compliance.

CAPA & non-conformance management

Resolve issues quickly with full traceability.

Capture and manage CAPAs, nonconformances, and corrective and preventive actions in one place, with linked documentation, assigned tasks, and real-time tracking to quickly address root causes.

Keep your CAPAs on track

Use a dedicated CAPA workflow to set tasks and monitor deadlines as you progress through investigation, analysis, and verification.

Eliminate data silos

Avoid the human error that comes with spreadsheets and binders by housing all your CAPA and nonconformance data and documentation in a single system.

Move from reactive fixes to proactive resolution.

Close out CAPAs quickly, find trends in nonconformances, and generate audit-ready documentation that supports stronger quality management across your organization.

Quality data, KPIs, and continuous improvement.

Your eQMS gives quality leaders a connected view of CAPA, nonconformance, training, supplier, audit, complaint, and change data. Teams can monitor quality KPIs, identify recurring root causes, and move from reactive issue management to proactive quality improvement.

Audit management for supplier and internal audits with real-time visibility and complete audit trails

Take the pain out of audits.

62% of teams spend more time prepping for audits than working to improve quality. Greenlight Guru lets you run internal audits or supplier audits directly from your QMS, with findings, evidence, actions, and audit trails connected in one place.

Keep all your audit prep in view

Track findings, assign actions, and keep all your evidence in one place so you can always show a clear, continuous record of compliance.

Schedule and automate audit activities

Set planned quality audits as needed and then manage them with reminders and notifications to keep everyone on track.

Manage retraining and updates

Post-audit, schedule retraining and get visibility into events and completion tracking to keep your training program compliant.

Run internal audits, supplier audits, and compliance audits from one QMS

Plan audit programs, schedule internal audits, manage supplier audits, assign findings, track corrective actions, and keep objective evidence connected to the records auditors need to see. The platform helps teams connect audit findings to CAPA, training, supplier evaluation, document updates, quality events, and compliance requirements, so audit prep becomes a continuous process rather than a last-minute scramble.

Design controls and DDF management across the product lifecycle

Automatically build a living DDF

Link user needs, inputs, outputs, verifications, and validations automatically to create a dynamic DDF that stays audit-ready from day one.

Link as you work

Add requirements, connect risks, and flag verifications without leaving the workspace or interrupting your team’s flow.

Flag traceability gaps before they become blockers

AI checks your requirements for verifiability, while real-time trace graphs expose missing links across design, risk, and test.

Stay audit-ready at all times

Every element is versioned, reviewable, and export-ready, so you’re always ready for inspections, without scrambling.

What can you do with Greenlight Guru?

Find answers and gaps faster with AI

Use AI-supported workflows to summarize QMS context, assess change impact, create training checks, and surface missing or affected records. Teams can quickly identify requirements missing verification, training triggered by an SOP change, supplier-related quality events, and records that need review before an audit.

Turn quality data into action

Monitor CAPA status, nonconformance trends, training gaps, supplier issues, audit findings, complaints, change records, and overdue tasks in one connected system. Use that visibility to identify recurring root causes and prioritize the business processes that most affect product quality and compliance.

Connect complaints to post-market quality

Link complaints and field issues to affected products, suppliers, risk controls, documents, CAPAs, nonconformances, and changes. This helps teams distinguish isolated events from recurring signals and keep post-market quality connected to the Risk Management File.