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SIMPLIFY MEDICAL DEVICE PRODUCT DEVELOPMENT

Do more value-added engineering work and less

compliance paperwork.

 

See it in action →

 

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1
Streamline the management of device requirements, risk, design reviews, and documentation. 
2
Device submissions are expedited and audit readiness is inherent to the software.
3
Easily demonstrate traceability between Design Controls and Risk with fully integrated risk management.
4
Drive accountability and collaboration across distributed teams to assure key development milestones are met.
5
Enable a renewed focus on developing better medical devices by focusing on value added tasks.
   
  • 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 14971:2019

Built for medical device product development professionals

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DESIGN CONTROLS
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AUTOMATICALLY MAINTAIN FULL TRACEABILITY

Easily manage multi-level device requirements in your traceability matrix and generate a completed Design History File on demand. Create detailed design control objects, link complex configurations, and attach documents with one click. 

See Design Controls in action → 

 

RELATED EBOOK: Ultimate Guide to Design Controls for Medical Device Companies  Read the eBook

 

RISK MANAGEMENT
risk-management

GAIN NEW VISIBILITY AND MITIGATE RISK

Incorporate risk controls into the product development process with the only cloud-based risk management solution that aligns with ISO 14971:2019. Demonstrate a risk-based approach to design with full traceability to related Design Controls and Components.

See how teams are taking an integrated approach to product risk→ 

 

RELATED EBOOK: The Definitive Guide to ISO 14971 Risk Management for Medical  Devices  Read the eBook

PROJECT MANAGEMENT
project-management

ACCELERATE DEVICE DEVELOPMENT TIMELINES

Meet aggressive deadlines by providing a centralized workspace where one or many teams can see each other's updates in real-time.

With FDA and ISO controls built-in, your team can stop wasting time chasing signatures, documenting offline design reviews, searching through email threads, and dealing with messy design transfers.

See how companies are launching medical devices faster with Greenlight Guru→ 

 

SUCCESS STORY: How Myolyn gained 510(k) clearance 48% faster than average with  Greenlight Guru  Read the Success Story

COLLABORATION
unified-visibility

ACHIEVE UNIFIED VISIBILITY

Drive accountability by managing device requirements and development efforts in a centralized workspace enabled with added-text formatting to enhance the technical details. Leverage tasks and flexible review and approval workflows to collaborate with internal and external stakeholders. 

See how teams are collaborating with Greenlight Guru→ 

 

SUCCESS STORY: How SimplicityMD used Greenlight Guru to explain complex  processes  Read the Success Story

LEARN MORE ABOUT GREENLIGHT GURU'S

DESIGN CONTROL AND RISK MANAGEMENT SOFTWARE

 

GLOBALLY TRUSTED, NO MATTER THE DEVICE

COMPLEXITY OR COMPONENT TYPES.

 Hardware   Software   SaMD

G2 - Spring 2020 (1)-1Leader - Fall21

G2 provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.

Read All Reviews

August 7, 2017
“Fantastic Product and Even Better Team”
The GG team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and are always trying to improve their software and user experience.
Ryan Shelton
Validated Reviewer
Verified Current User
May 22, 2018
“One Stop Shop for MD QMS”
I love that everything is 'under one roof', the design, document control, training, change management, NC,s CAPAs, Feedback and Audits. I really love the risk within design, it is set out clearly, easy to use and clear to see the risks at a glance. I also love that Greenlight have a continual improvement approach and new features being added to enhance the usability and performance from time to time. Also, their customer service is top class. I really don't know how I would do my job without it!
Maria McGrady
Validated Reviewer
March 25, 2021
“Simplified Traceability and Risk”
I love how simple the program is and how it takes a lot of time-consuming unnecessary information found in historical QMS systems and replaces it with the critical focused details to move things along quickly.
User in Medical Devices (Mid-Market)
Validated Reviewer
Verified Current User
March 22, 2021
“Great software for QMS activities and document management”
As a small business implementing a QMS for medical device design/manufacturing, it has proven to be an incredibly valuable tool.
Jason C.
Validated Reviewer
Verified Current User
April 1, 2021
“A very good start with GG!”

With Greenlight Guru, I can follow all the steps of our quality management system and make sure all regulatory requirements are met. The most significant benefit for me is being able to accurately verify that all risks are managed and that all design checks are carried out. The software allows us an extremely rigorous follow-up which is and will be a big help for us.

Camille
Validated Reviewer
April 1, 2021
“Greenlight Guru has made Design Controls and Project Planning easier to execute and manage”

We are solving document control and design controls with the Greenlight Guru Software. It is easier to release documents and gather signatures for controlled documents. The design controls system has made project management more manageable by having all the documents in one place.

Mike S.
Validated Reviewer
Verified Current User
March 26, 2021
“Demystifying QMS and Regulatory Requirements”

The Greenlight Guru customer success team has helped us navigate the entire process so far, with no ask too large and no question left unanswered. It has by far been one of the best customer service experiences I've had to date.

Kyle P.
Validated Reviewer
Verified Current User
March 16, 2021
“You do not have to do it alone!”

Having come from one of the largest medical device companies globally to a start-up with no QMS, yet alone, an eQMS, the transition to Greenlight has saved my team countless hours and provided an ability, especially during COVID, to do remote approvals of documents, assign tasks, and give visibility to the appropriate team members of a variety of modules in order to collaborate and move forward with pre- and post-market activities.

Adam C.
Validated Reviewer
Verified Current User
March 26, 2021
“Modern QMS Software and Outstanding Customer Service”

#1 - Customer Service! Our Customer Success Manager and Medical Device Guru are both incredibly patient and responsive anytime that my team and I email them questions. They are also genuinely appreciate unfiltered feedback from their customers. Their positive attitudes and attentiveness, specifically throughout our onboarding process, has been instrumental to our success in implementing GG. We did NOT feel like we were left on our own during this process.

Amanda P.
Validated Reviewer
Verified Current User
March 13, 2021
“Greenlight Guru allowed us to get our QMS up and running in less time than we ever thought possible”

The biggest gain for us has been being able to get our QMS up and running from scratch in less than 3 months. It is reassuring knowing that the system helps us to be ISO 13485 and 14971 compliant. We have found GG to be very useful in documenting our design controls and risk matrix. We really like how the system allows you to connect these areas.

Azeret Z.
Validated Reviewer
Verified Current User

Ready to get started doing more value added engineering work and less compliance paperwork?

See the Demo