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Be Audit Ready at a
Moment’s Notice

Greenlight Guru provides a connected quality ecosystem where every record of your QMS is organized, centralized, and traceable. Be ready for any type of audit, at any time with full confidence (and some peace of mind). Consider us an extension of your team — we’re here to help.

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Critical Step

Having audit processes in place and teams trained on those processes is essential for long-term success. Internal audits, external audits, supplier audits, FDA audits—the list goes on. Avoid overcomplicating these processes. Leverage an easy to use, task-based, organized, and seamless solution.

800+ of the world’s leading MedTech companies trust Greenlight Guru.

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Take the Anxiety Out of Audits

We know audits are a necessary yet stressful part of our industry. Greenlight Guru is here to help drive a positive audit experience every time. We will also be there to celebrate your successes with you.

Lead With Confidence

Successful audits are a competitive advantage and should be treated as such. When you’re confident your system is compliant, you’re already ahead.

Centralize Your Source of Truth

Audits don’t have to be complicated. Say goodbye to piles of paperwork and hours in your audit war room. Have full visibility and traceability into any document you may need and even ones you may have initially missed.

Embrace Every Audit

Be ready for all audits— even remote ones. Our cloud-based system ensures the challenges of paper-based audits are in the past and that everything you could possibly need is only a few clicks away.

Being Compliant is Key

Whether its ISO 13485, ISO 14971, 21 CFR Part 11, 21 CFR Part 820, EU MDR or another one of the many acronyms — our workflows ensure your processes adhere to the industry’s requirements and best practices.

Conduct Audits With Ease

We are here to alleviate common audit anxieties so you can focus on building compliant life-changing medical technologies.

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Don’t Leave Audits up to Chance

Don’t let the fear of fines, penalties, and product recalls keep you up at night. With Greenlight Guru, you can be audit-ready at any moment, which means more life-changing products in the market faster.

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Explore Our Resources

Regulatory Submission

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Episode 242

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Regulatory Submission

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

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Regulatory Submission

Understanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive

A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, and ...

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