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Design Control Software

The New Era of Design Control Is Here

Focus on designing and delivering life-changing MedTech products. Leave gaps and disconnects in the past. Move forward with design control management that keeps innovation, quality, and traceability at the forefront.

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

Design Control

Maintaining Traceability Shouldn’t Slow You Down

Using paper-based solutions and disconnected systems to achieve traceability is expensive and time-consuming. Ensuring visibility and connectivity between inputs, outputs, verifications, and validations is not an easy feat. Your QMS should drive collaboration for design actions, 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.

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

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.


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


months faster to market


hours saved on low value-added activities