And that's a wrap for LSIUSA! 🎉 A huge thank you to all the incredible founders & funders who joined us for an unforgettable evening at our exclusive executive dinner and for the many people we met at the show this week. At Greenlight Guru, we believe that bringing together the brightest minds in the industry leads to impactful change—and this week was a true testament to that. Until next time! Pall Johannesson Andy Rogantino Christine Wilbert Fabi Rocha Etienne Nichols 🎙️
Greenlight Guru
Software Development
Indianapolis, Indiana 22,614 followers
Moving MedTech Forward with our leading Quality Management System and Clinical Data Capture software
About us
Greenlight Guru is the #1 provider of modern cloud-based QMS & EDC solutions for the MedTech industry, helping companies bring life-changing products to market faster, more efficiently, and with less risk. Greenlight Guru’s MedTech Suite provides quality management, product development, and clinical data management solutions, along with high-quality training and education required to keep up with the rapidly changing industry regulations. With Greenlight guru, teams are improving efficiency, speed, and quality in every aspect of their organization to get products to market faster and keep them on the market longer. For more information, visit www.greenlight.guru
- Website
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https://www.greenlight.guru
External link for Greenlight Guru
- Industry
- Software Development
- Company size
- 201-500 employees
- Headquarters
- Indianapolis, Indiana
- Type
- Privately Held
- Founded
- 2013
- Specialties
- Medical Devices, Design Control, Regulatory Compliance, Quality Management, Risk Management, FDA 510(k), Document Control, QMS software, Quality Management System, ISO 13485, ISO 14971, FDA 21 CFR Part 820, FDA 21 CFR Part 11, Post-Market Surveillance, Quality System Regulations, Electronic Data Capture (EDC), ISO 14155, Clinical Data, Clinical Investigations, EDC System, and Clinical Data Capture Software
Locations
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Primary
601 S Meridian St
Suite 2H
Indianapolis, Indiana 46225, US
Employees at Greenlight Guru
Updates
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We're #hiring - we'd love it if you shared with your network! 🚀
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We're #hiring - we'd love it if you shared with your network! 🚀
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We’ve kicked off #LSIUSA2025 and Greenlight Guru is thrilled to be part of this premier event, where industry leaders, investors, and innovators come together to shape the future of medical devices. Looking for ways to accelerate time to market? We’re here to help. Stop by or book some time to chat with us via the LSIUS app. Pall Johannesson Christine Wilbert Etienne Nichols 🎙️Maansi Shah Andy Rogantino Fabi Rocha
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2025 Medical Device Industry Report: Quality Challenges, Regulatory Complexity, and Economic Uncertainty https://bit.ly/3E0zNhL
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The 2025 Medical Device Industry Report is here! 📢 We surveyed 500+ industry professionals to pull back the curtain on the biggest challenges, opportunities, and trends shaping the medical device industry this year. 📊 Key Findings: -Economic pressure is high – 37% of companies are implementing hiring freezes, and 33% are delaying new product development. -Regulatory uncertainty is a major hurdle – Only 25% of pre-commercial companies feel highly prepared for EU MDR, and just 16% for QMSR. -Data silos are stalling growth – Nearly two-thirds of large companies struggle with disconnected data, limiting collaboration. -Outdated tech is holding companies back – 56% still rely on paper-based tools for clinical data, and 69% lack confidence in their QMS. Download the full report now! 🔗https://bit.ly/4kRFoaN We’re also breaking down the findings LIVE! Join our upcoming 2025 Medical Device Industry Report webinar on March 26th, where industry experts will discuss what these insights mean for your business and how to navigate the year ahead. You can register via the link in the comments below. ⬇️
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🚨 Cybersecurity & Hidden Threats in Medical Devices: Real-World Risks & the Evolving Regulatory Landscape 🚨 As software-driven medical devices become more interconnected, cybersecurity and risk management have never been more critical. The threats are real, and global regulators are paying close attention. Join us for this webinar where industry experts Etienne Nichols, Ken Zalevsky of Vigilant Ops, Inc. and Joseph Sylvia of Medware Cyber will explore real-world medical device vulnerabilities and share strategies to mitigate cyber risks while staying compliant with evolving regulations. Key takeaways: ✔️ Real-world case studies of medical devices compromised by cyber threats ✔️ Insights into regulatory expectations (FDA, EUMDR) ✔️ Actionable strategies to protect your devices and ensure compliance 🗓 Date: March 27 ⏰ Time: Noon Eastern Time 📍 Register now: https://bit.ly/3RcMNUr
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Greenlight Guru reposted this
LSI USA ‘25 Workshop Just Announced: Ask Us Anything and Test Your Knowledge — State of the Medtech Market and Venture Ecosystem This workshop takes a data-driven look at the state of Medtech in 2025, covering industry trends, regulatory challenges, and the evolving investment landscape. Expect key insights from the 2025 Medical Device Industry Report, along with an analysis of Medtech financing and exit activity. Get answers to your biggest questions in an AMA-style discussion while putting your industry knowledge to the test in a fun interactive quiz to learn about top device indications, the current temperature for funding PMA pivotal trials and 510(k) commercialization rounds, and trends in private M&A activity. This workshop is led by: • Etienne Nichols 🎙️ — Head of Industry Insights & Education, Greenlight Guru • Jonathan Norris — Managing Director, HSBC Innovation Banking There is still limited availability to attend LSI USA ‘25 on March 17-21 in Dana Point, California. Apply today to secure your spot while space is still available: https://lnkd.in/gS2KF_wr
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Greenlight Guru reposted this
Fired up to be attending LSI USA '25 in Dana Point, CA next week! As one of the premier MedTech events each year - its looking like a great opportunity to engage with industry leaders, visionaries, and strategic partners. If you'll be at #LSIUSA25 let’s connect! Feel free to reach out or swing by the Greenlight Guru booth to say hello to myself Fabi Maansi Christine Pall and Etienne! And don't miss Pall Johannesson's sessions during the week!
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Greenlight Guru reposted this
Greenlight Guru will be strongly represented next week at #LSIUSA25 by the group of experts below. Be sure to stop by and see us to share your story and hear how we have been helping companies like yours in the MedTech space get devices to market faster!
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