Why Switch

Greenlight Guru streamlines quality management for medical device companies

Implementing a quality management software solution for your medical device company may seem like a hefty task. That is why we’ve answered the top 10 questions that we hear from innovators like you.

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1

Isn’t switching to an eQMS a time-consuming effort?

Switching to an eQMS does not have to be a burdensome process. In fact, with Greenlight Guru it isn’t!

We have several different means of helping teams transition their existing QMS documents and data into our platform. Depending on the prioritized use case for your company, this transition time to value can be seen within two to eight weeks.

Our team will work with you to define and establish a plan for transitioning existing documentation and a dedicated medical device industry expert will work closely with you to define how your processes will translate into your eQMS with Greenlight Guru.

2

How will the benefits of adopting an electronic quality system translate into success for my company?

Almost immediately customers will realize the benefits of digitizing and automating their QMS with Greenlight Guru.

Our medical device quality management software platform enables teams to:

  • Launch new products faster
  • Simplify quality processes
  • Manage risk with ease
  • Maintain end-to-end traceability between design controls and risk management, and post market surveillance
  • Full visibility into their quality ecosystem
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What is different about Greenlight Guru?

Greenlight Guru is the only electronic quality management system software that is purpose built for the medical device industry allowing you to implement faster, scale as you grow, and know it will be easy to use for your team.

Unlike general purpose quality management  solutions, or those focusing on the life science industry, Greenlight Guru’s quality platform enables teams with integrated Design Controls and Risk Management to provide the total product lifecycle management (TPLC) regulators are now looking for.

With our medical device industry Guru’s we offer more than a software - we offer a partnership.

Our team stays in the know about industry best practices and changing regulatory climates to build a platform that allows your team to focus on the quality of your device, not just compliance.

No matter the in-house experience your team has, our medical device Guru’s are equipped to provide guidance for a wide-range of industry-related topics that will steer your team in the right direction.

4

I have already passed audits and reached other milestones with my current system, why should I switch?

Just because a 16 year old gets their license, doesn’t mean they’re a good driver. Just because you passed an audit, doesn’t mean your quality management system is set up to reach your next milestone.

Using Greenlight Guru provides a unique advantage for your company and product’s lifecycle regardless of the milestones you have already reached or plan on tackling in the near future. Having a centralized system to organize and manage your documents, design controls, risk management, and your post-market quality processes maximizes the effort to reduce cost and nonproductive hours in the future.

Being proactive and choosing to lead with quality through Greenlight Guru’s QMS software can keep you company not only prepared for your next audit or milestone, but ahead of changing regulatory requirements.

3

Who on my team will benefit from using Greenlight Guru?

Whether it be product development, quality and regulatory, partners, or company executives, everyone on your team can benefit from using Greenlight Guru’s MD QMS software!

By assigning distinct roles and responsibilities, administrators can control who has access to the software and what they are responsible for and/or contribute in the system. Because our quality management software is 100% cloud-based, everyone on your team can access Greenlight Guru via a standard web browser enabling better collaboration and efficiency throughout your product’s lifecycle.

5

Isn't it super time consuming and expensive to validate software to 21 CFR Part 11?

Not with Greenlight Guru! We're able to alleviate those efforts and streamline your processes through our multi-tenant, medical device specific, cloud-based SaaS platform.

According to a LNS Research ‘State of the Market’ piece on Software Validation in the Life Sciences industry, they assert, “Cloud-based technologies create new opportunities to streamline validation [and] industry leading vendors are providing pre-validated platforms, pre-validated functions, and pre-validated pre-configurations.”

This article goes on to describe the “no-effort" approach we’ve pioneered with our software, establishing an automated system for the validation process. Ultimately we provide companies a steadfast track for compliance with 21 CFR Part 11 by proving IQ protocols and checklists, and completed OQ/PQ reports for no additional charge.

8

What industry specific regulations will Greenlight Guru help me comply with?

We work with all classifications of medical devices in more than 600 cities, on 6 different continents. With Greenlight Guru, you can streamline compliance for product development and quality processes, allowing your team to focus on quality regardless of device class or intended market.

Our workflows are aligned to FDA and ISO standards for medical device predefined processes, which include:

  • FDA 21 CFR Part 820
  •  ISO 14971
  •  FDA 21 CFR Part 11
  •  IEC 60601
  •  ISO 13485:2016
  •  IEC 62304

Implementing Greenlight Guru and gaining clarity on your compliance efforts can help you navigate and proactively prepare for the changing regulatory climates surrounding FDA Case for Quality, EU MDR, and MDSAP requirements.

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How can I convince leadership at my company?

We get it, quality has historically been viewed as a cost center that many medical device companies don’t actively invest in. A significant number of our existing customers were initially hesitant in their ability to get leadership buy-in for switching from a paper, ad-hoc, or legacy QMS to a modern medical device quality management software.

By building a business case for connected quality, you can highlight both the value-added strategic benefits in achieving the companies goals, as well as the financial impact the software will have on the company. 

Upgrading your QMS to Greenlight Guru shouldn’t be viewed as an expense, but rather a strategic investment in better outcomes for your devices, customers, employees, and business. Once you demonstrate to leadership how quality positively impacts both the top and bottom line, there is a good chance that they’ll see the ROI. 

6

If I have a question or an industry-specific need, how will the team at Greenlight Guru help me?

Every customer is paired with a dedicated medical device industry expert to schedule live sessions to guide you through the on-boarding process and get your team up to speed with using our software.

For customers that need supplemental on-boarding or training services that go beyond our standard on-boarding process, we will work with your team to define an extended scope of training and advising for software best practices and next steps to guide your team to specific milestones in your quality transformation. Our team can consult and guide you through product development activities, preparation for regulatory submissions, gaining certification, and much more.

For immediate help, our in-app Help Center also allows customers to access training and support articles and videos on navigating the software.

7

Is there an ideal time to switch?

Whether you are:
  • launching a new device
  • entering a new market
  • prioritizing quality
  • scaling your company
  • working to improve product development efficiency
  • or beginning remediation activities 

Now is the ideal time to switch to Greenlight Guru! Our platform offers your team immense value right out of the box. There is no additional time for configuration and the intuitive user interface gets teams learning and navigating the system with ease.

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