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Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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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.

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1,000+ of the world’s leading MedTech companies trust Greenlight Guru.

Product-4

Easily Build and
Manage Your BOMs
for Better Results

Many medical device companies start out managing bills of materials (BOMs) in spreadsheets and disconnected solutions. That doesn’t mean you should. Define your product families and manage your multi-level BOMs in a purpose-built platform, seamlessly connected to your QMS, design controls, document management, and quality processes.

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Your Solution for Continuous Product Management

Go beyond design controls. Create and collaborate on product development activities with the necessary connections to your Design History File (DHF) and quality actions, all in one place.

Close the Gaps

Make everything in product development work better when you build out your devices (Product Families, Items, BOMs, and more) in Greenlight Guru with the rest of your medical device information. Decrease risk, speed up development, and reduce costs with an end-to-end solution.
Gain Control

Streamline engineering change management to track the evolution of your medical device BOMs. Empower your team to move fast on changes with everything connected for an easy and compliant approval process.

Organize for Specific Needs

Group your medical device BOMs by product families to support industry-specific registration requirements. Benefit from full traceability and visualization of products in the family, down to the component-level.

Focus on Innovation and Continuous Development

Free up your team’s most precious resource—time. Gain confidence with an end-to-end solution designed specifically for the MedTech industry.

Capture the Information That Makes Up Your Medical Device

Build your multi-level BOMs, add the required details, and easily publish when ready.

Build Out Product Families

Organize by location, process, manufacturing site, type of product, and language to meet registration requirements.

Manage Changes to BOM Components

Route, review, and approve any changes made to items living in your BOM for full traceability.

Create a Seamless Flow of Your Product Data

Bring your quality, design, and development processes together by linking BOM items to documents and quality events.

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Benefits for Teams

Designed With Your Entire Organization in Mind

Build your BOM as you design and then continuously document changes to your BOM as you progress to commercialization.

For Product Teams

Inject quality into product development activities

  • Fulfill ISO 13485 requirements and ensure everyone has access to the latest approved product design
  • Track revisions of your items: mechanical, electrical, and software
  • Achieve traceability between design history file (inputs) and product development work (outputs)

Benefits for Teams

Designed With Your Entire Organization in Mind

Build your BOM as you design and then continuously document changes to your BOM as you progress to commercialization.

For Quality Teams

Ensure effective product management as you grow

  • Update and manage your BOMs throughout the lifecycle of your products
  • Efficiently collaborate across your teams
  • Control the entire product design from electrical, mechanical, and software to packaging, labeling, and work instructions

For Executive Teams

An all-in-one solution for all of your teams

  • Enhance quality and product development collaboration
  • Manage all your critical medical device data in one place
  • Easily expand into more of the the platform as you progress in your device journey and have new needs
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Collaborate With Suppliers

As devices change with updates or as a result of quality events, use Greenlight Guru Products to guide you in communicating your updates across teams. Tag your BOM items with supplier information for an added level of detail.

See An Entire BOM Built Out In Our Product Management Solution

Chat with our industry experts to learn how you can manage all your quality and development efforts in one place.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

1000 +

other approvals and audits passed