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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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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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

Get a personalized demo of Greenlight Guru Clinical today.

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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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Design Control Software

Streamline Design Controls With Ease and Compliance

Improve the design and development process while driving collaboration and ensuring compliance. Document, track, and trace all aspects of your design control process to bring high-quality devices to market faster.

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1,100+ of the world's leading MedTech companies trust Greenlight Guru.

Design Control

Documenting Design Controls Shouldn’t Slow You Down

Documenting the design control process is complex, manual, and prone to errors. Avoid delays in product development and regulatory submissions by ensuring visibility, connectivity, and compliance.

Our multi-level traceability matrix is the most powerful and flexible way for you to manage your complex medical device products, link documents, conduct project reviews, and generate a design history file — all with a single click.

The #1 Design Control Software for
Medical Devices

Leverage Greenlight Guru Design Control Software to improve your design processes and document your design while staying compliant.

Improve Efficiency

Eliminate data silos. Create and update your traceability matrices and schedule a design review in mere minutes — not hours or days.
Obtain Traceability

Create your design control objects, link complex configurations, and attach related documents with a single click. Leave behind the days of scouring your desktop files for the data or documents you need.
Connect to Risk Management

Bring safe and effective products to market faster. Incorporate risk management while you design to mitigate issues as early as possible.
Stay Audit Ready

Provide auditors and inspectors with the signatures and objective evidence they require — on-demand.

Powerful Traceability Doesn’t Need To Be Complex

Designed specifically for MedTech professionals with simplicity and flexibility in mind.

Conduct Digital Design Reviews

Collaborate and track design reviews with Part 11 compliant workflows.

Track Research & Development Activities

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

Maintain a Living Design History File

Generate design history files and records without searching for the required documentation.

Link Design to Risk

Prioritize ISO 14971 and ensure compliance while you design your devices.

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Designed With Your Entire Organization in Mind

Benefits for Teams

Design Controls touch every part of your MedTech teams, so we make sure that our solution does too.

For Product Teams

Streamline design processes so you never miss a step

  • Spend more time designing and less time doing paperwork
  • Collaborate with your R&D team on verification and validation testing
  • Link all relevant documents, specifications, and design components together with a single click
Designed With Your Entire Organization in Mind

Benefits for Teams

Design Controls touch every part of your MedTech teams, so we make sure that our solution does too.

For Quality Teams

Maintain true quality, traceability, and visibility with every project

  • Bring a safe, compliant device to market with a solution built specifically for the MedTech industry
  • Easily achieve 21 CFR Part 820.30 and ISO 13485 compliance with an auto-generating, auto-updating DHF
  • Prioritize ISO 14971 and access risk connected to design controls at anytime

For Executive Teams

Support rapidly growing teams and product lines

  • Bring your products to market on time
  • Eliminate data silos that increase costs and delays
  • Prepare for large regulatory approvals and expand business ventures with confidence
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Integrate with Jira

Enable product development teams to leverage the agile functionality of Jira while maintaining traceability to Design Controls processes throughout the MedTech lifecycle.
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Software as a Medical Device (SaMD)

Industry standards require that stand-alone software components be managed separately, just like the hardware and software components of traditional medical devices. Manage both your software components and devices through their own design workflow to ensure that each component is reviewed and approved as part of the whole product.

See More of Our Multi-level Design Control Software

Get a deep dive into our Design Control Software, ask questions, and see your multi-level design control matrix come to life.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities