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The only Quality Management Software designed specifically for the medical device industry.

Achieve End-to-End Traceability

Easily trace CAPAs all the way back to your design controls so your employees can focus on accelerating your business.


Automate Quality Processes

Integrate quality and risk management into your design and development processes from the start.


Follow FDA/ISO Best Practices

The only software with the latest FDA and ISO best practices specific to medical device companies built into every feature.

Streamline Team Communication

Communicate where your team works. Avoid unecessary meetings, emails and communication across apps.


  • 21 CFR Part 11 Compliant
  • Workflows aligned to FDA and ISO standards for medical device predefined processes
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971

Premarket Quality Management Software

BRING SAFER, BETTER MEDICAL DEVICES TO MARKET FASTER.

  • Design Control
  • Document Management
  • Risk Management

BRING SAFER, BETTER MEDICAL DEVICES TO MARKET FASTER.

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DESIGN CONTROL
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AUTOMATICALLY MAINTAIN FULL TRACEABILITY.

Update your traceability matrices in minutes, not hours or days. Then easily export records on-demand.

Create design control objects, link complex configurations, and attach documents with one click.

Generate design history files without searching for the required documentation.

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DOCUMENT MANAGEMENT
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EASILY ACCESS UP-TO-DATE DOCUMENTS.

Save time with Part 11 compliant e-signatures, auto document routing, revision control and more.

Know that your team is always working off the most current version of a document.

Find documentation during audits and inspections without chasing down stakeholders and documents.

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RISK MANAGEMENT
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GAIN NEW VISIBILITY AND MITIGATE RISK.

The only cloud-based risk management solution that aligns with ISO 14971.

Visualize the relationships between requirements, risks, and verification tests.

Keep your risk management file up to date and avoid costly rework by mitigating potential risks.

Want to learn more about our Premarket Quality Management software? Let us show you around Greenlight Go.

See the Demo
NEW

Postmarket Quality Management Software

ADVANCE THE
QUALITY OF YOUR MEDICAL DEVICES
AND CONTROL RISK.

Remain compliant and manage risk in the face of ISO and FDA changes.


Identify CAPAs, discover their root causes, resolve them, and report outcomes.


Manage feedback and complaints, escalate when appropriate, and update your risk management file.


Conduct internal audits and always be ready for external audits and inspections.

ADVANCE THE
QUALITY OF YOUR MEDICAL DEVICES
AND CONTROL RISK.

  • Audit Management
  • Complaint Management
  • CAPA Management
  • Nonconformance Management
  • Change Management
  • Training Management
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CAPA MANAGEMENT
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IDENTIFY AND ADDRESS ISSUES FASTER.

Easily trace CAPAs back to their root cause, even if it’s in design control.

See quality issue trends in real time and correct them before they become a regulatory issue.

Assign CAPA-related tasks to your team, include guidelines, and track everyone’s progress towards due dates.

Access your procedures and present them to the FDA in a couple of clicks.

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AUDIT MANAGEMENT
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CONDUCT AUDITS
WITH EASE.

Manage tasks, follow ups, communications, and any actions that result from audit findings.

Escalate high-risk findings for investigation and monitor low-risk findings for recurrence.

Create and share final audit summaries with a single click.

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COMPLAINT MANAGEMENT
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STREAMLINE FEEDBACK AND COMPLAINT PROCESSES.

Quickly determine whether feedback requires immediate action or the issuing of a CAPA.

Ensure your customer complaint processes are compliant and easily audited by regulatory bodies in any country.

Optimize customer feedback management and oversight for faster response times.

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NONCONFORMANCE MANAGEMENT
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REDUCE CYCLE TIMES AND ASSOCIATED RISKS.

Easily capture defect details such as part, quantity, failure type, and severity.

Adjust workflows based on risk and loop in the right team members and suppliers to resolve issues quickly.

Escalate the right defects to CAPAs at the right time.

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CHANGE MANAGEMENT
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UNDERSTAND AND MANAGE THE IMPACT OF ANY CHANGE.

Identify scope, understand impacts, justify the change, and document decisions before anything is implemented.

Link any item within Greenlight Guru including change records, documents, risks, design controls, CAPAs, customer complaints, audits and nonconformances.

Realize full traceability and auditability throughout.

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TRAINING MANAGEMENT
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THE RIGHT TRAINING TO THE RIGHT PEOPLE AT THE RIGHT TIME.

Assign training to individuals, set due dates, and keep track of tasks to ensure training completion.

Provide links within the software to related documents, videos and presentations so all required training material is easily accessible.

Know what training is in process, who has completed it, and view all historical data to ensure the right people received proper training.

Want to learn more about our Postmarket Quality Management software? Let us show you around Greenlight Grow.

See the Demo