blog.greenlight.guru

greenlight.guru

Customers of greenlight.guru

http://www.greenlight.guru/customers

Webinars, Ebooks and Guides. Happy to Call Some of the World's Most Innovative Medical Device Companies Our Customers. Greenlight.guru helps your team build amazing devices faster with less risk. What Some of Our Customers Are Saying About Us. Gabriel Sanchez, CEO. We dug deeper to see how other friends we knew were handling their QMS needs and after adding up time, consultant fees, etc. we felt greenlight.guru was the right tool for the job. Nick Damiano, CEO and Co-founder. David Narrow, CEO. Because y...

greenlight.guru

Quality Management Software | greenlight.guru

http://www.greenlight.guru/quality-management-software

Webinars, Ebooks and Guides. The Only Quality Management Software Made Exclusively for Medical Device Companies. Bring safe and compliant devices to market in less time and for less money. A Quality Management Software. That allows you to. Build quality management into your design and development processes instead of waiting for QA to catch issues when they are more expensive and difficult to fix. Follow FDA/ISO Best Practices Automatically. Inside of what is traditionally a less controlled environment.

greenlight.guru

Document Management Software | greenlight.guru

http://www.greenlight.guru/document-management-software

Webinars, Ebooks and Guides. Document Management Software -. Get your controlled documents, records and procedures into an eQMS with e-signatures, routing, revision control and more. Speed up reviews and approvals by keeping your documents organized, up-to-date and always accessible. Manage Your Controlled Documents. Know the status and maintain complete visibility of all your critical documents and records. Required to address FDA and ISO. Stop juggling multiple versions of the same document. Caused by ...

greenlight.guru

Medical Device Resources from greenlight.guru

http://www.greenlight.guru/medical-device-resources

Webinars, Ebooks and Guides. Free Medical Device Resources from greenlight.guru. To help your medical device company with product development, quality management and regulatory compliance. Ultimate Guide to Design Controls for Medical Devices. Step-by-step Guide to Complying with ISO 13485 and FDA QSR. Definitive Guide to ISO 14971 Risk Management. The greenlight.guru Advantage - More Than eQMS Software. Guide to Design Verification and Design Validation. 15 Items Medical Device Startups Need to Address.

greenlight.guru

Careers | greenlight.guru

http://www.greenlight.guru/careers

Webinars, Ebooks and Guides. We persevere. Regardless of how tough things get or how distant the goal is, we keep moving forward. One eye on the horizon, one eye on the step in front of us. We're an assortment of bright, talented, and interesting people united by the mission to change the way people make medical devices. We want people who can solve challenging problems, make a real impact and build something big. We love what we do! We're a tech company to the core. We strive for something better. View ...

greenlight.guru

Medical Device Startup Program Scholarship | greenlight.guru

http://www.greenlight.guru/medical-device-startup-program

Webinars, Ebooks and Guides. Introducing greenlight.guru Fast Lane. A Program For Seed-Stage Startups. Add some jet fuel to your product development efforts and extend your runway with greenlight.guru's eQMS software for a fraction of the cost. Jump in the Fast Lane! What is greenlight.guru Fast Lane? This program gives you access to the complete greenlight.guru quality management platform. Now all of that power is available to even the earliest stage startups. Now there's greenlight.guru Fast Lane.

greenlight.guru

Quality Management Software Features | greenlight.guru

http://www.greenlight.guru/quality-management-software-features

Webinars, Ebooks and Guides. If you think all QMS solutions are the same, let me introduce you to greenlight.guru. Exclusively designed for medical device companies, greenlight.guru is better than paper, smarter than Excel and SharePoint, and easier than legacy commercial EQMS Solutions. The greenlight.guru Platform. The greenlight.guru Platform. Designed for FDA 21 CFR Part 11 Compliance. With a system designed specifically to comply with Part 11, ensuring compliance becomes much simpler. Sign off on pr...

greenlight.guru

Medical Device Consulting | greenlight.guru

http://www.greenlight.guru/medical-device-consulting

Webinars, Ebooks and Guides. More than just software. Medical device consultants with decades of experience. Having trouble interpreting the latest regulatory guidelines? Need some extra help getting prepared for an audit? Not sure where to start with your 510(k) submission? Have any other regulatory or quality related questions? Contact a guru today to learn more about how you can. Benefit from our services. Proven professionals always just a phone call away. Talk To An Expert. Call us at (317) 960-4220.

greenlight.guru

Quality Management Software | greenlight.guru

http://www.greenlight.guru/quality-management-software-tour

Webinars, Ebooks and Guides. The Only Quality Management Software Made Exclusively for Medical Device Companies. Bring safe and compliant devices to market in less time and for less money. A Quality Management Software. That allows you to. Build quality management into your design and development processes instead of waiting for QA to catch issues when they are more expensive and difficult to fix. Follow FDA/ISO Best Practices Automatically. Inside of what is traditionally a less controlled environment.

meddeviceonline.com

5 Tips To Help Your FDA 510(k) Submission (Checklist Included)

http://www.meddeviceonline.com/doc/tips-to-help-your-fda-k-submission-checklist-included-0001

July 16, 2015. 5 Tips To Help Your FDA 510(k) Submission (Checklist Included). Founder and VP of QA/RA, greenlight.guru. If you are developing a medical device in the United States, there is a good chance your path to market involves a. Over my career, I have had a part in putting together several 510(k)s. Within the past year, I’ve had the pleasure of authoring a couple FDA 510(k) submissions on my own from scratch, a. Nd I have learned a ton from these most recent FDA 510(k) submissions. If accepted, y...