Last roadshow of 2024: Salt Lake City, here we come! ?? Join us October 3 for an exclusive opportunity to connect with MedTech leaders and local professionals while gaining insights from industry experts like Christopher Phillips, MSHS, RAC, CMDA, Edwin Lindsay and Thor Rollins. ?? This panel will address the top challenges, strategies & opportunities in the medical device industry, that impact product development and quality management. ???? Plus, you’ll have the opportunity to network with peers and discuss real-world strategies to improve quality and regulatory processes. ????? Our events tend to fill up quickly, so claim your seat before it's too late: https://lnkd.in/eTsk4Dya.
Greenlight Guru
软件开发
Indianapolis,Indiana 21,483 位关注者
Moving MedTech Forward with our Leading Quality Management System and Clinical Data Capture Software
关于我们
Greenlight Guru is the #1 provider of modern cloud-based 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.
- 网站
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https://www.greenlight.guru
Greenlight Guru的外部链接
- 所属行业
- 软件开发
- 规模
- 201-500 人
- 总部
- Indianapolis,Indiana
- 类型
- 私人持股
- 创立
- 2013
- 领域
- 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和Clinical Data Capture Software
地点
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主要
601 S Meridian St
Suite 2H
US,Indiana,Indianapolis,46225
Greenlight Guru员工
动态
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What about the EU AI Act? Have you ever ?been in the middle of a conversation and thought to yourself, ?“Why are we not recording this?!” That happened to me with Anjany from bonescreen who was on a panel yesterday at LSI discussing the European AI Act. Not being a true software guy, this is my translation… The ?EU AI Act primarily imposes new regulatory requirements for companies utilizing artificial intelligence in their products, especially in high-risk sectors like healthcare. MedTech companies that are already familiar with EUMDR will likely face additional checks and compliance measures specifically for the AI components of their devices, like algorithm transparency, bias prevention, and continuous performance monitoring to ensure patient safety. For companies already embedded in the regulated healthcare ecosystem, however, the incremental burden might be modest compared to industries that are newer to regulation. So, in that case, the focus is more along the lines of adapting existing compliance processes (audits, traceability, & documentation) to integrate AI-specific questions. If you’re an AI company, I’m curious what kind of impact you’ve felt from the AI Act – let me know! P.S. If you were having Medtech conversations in a monastery, you’d record every conversation too! ?? #ai #medicaldevices #lsieurope24 #greenlightguru
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From designing innovative devices to ensuring clinical validity and navigating complex market landscapes, IVD manufacturers face unique challenges at every step. That’s why we’ve created The Ultimate Guide to IVD Devices – your comprehensive resource for navigating the entire lifecycle of these products, from initial concept to market entry and beyond. Whether you’re defining your regulatory strategy or preparing for market access, this guide gives you everything you need to design, develop, and deliver impactful devices to patients. Read it now:https://hubs.ly/Q02Q4XCx0 #ivd #medicaldevices #medtech #guide #greenlightguru #invitrodiagnostics
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What happens when you run into one of your favorite conference buddies? You steal their tagline, of course! (I mean, a #MedtechInAMinute video series is pretty good...) But that's beside the point. The REAL point is to go to conferences to make conference buddies!!! So if you're at #LSIEurope24 this week, Weronika or I would love to meet. Stop by the panel I'm moderating, or the session she's leading today at 1:00pm and 4:00pm, respectively! Happy Tuesday! P.S. Next week will return to your regularly scheduled MedTechInAMinute - but let Weronika know what topic you want her to cover!! ??
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How easy is it to transition from a paper-based QMS to an eQMS? Etienne Nichols and I recorded a podcast about this a while back… Transitioning from a legacy QMS to an eQMS is no small feat. I’ve been on both sides of the process—first as a Quality Engineer helping to manage it, and now as a Medical Device Guru helping others make the shift. One of the most common questions I hear is, Where do we start? My advice? Begin with a solid plan. Establishing an implementation strategy right from the beginning is crucial. It guides you through the process and ensures that when the time comes for audits, you have a clear, documented path that shows how you got there. During my time in the industry, I helped manage the migration of a QMS with over ten years of records and multiple devices. I learned that even small, detail-oriented steps—like standardizing document headers and naming conventions—can pay off big time during audits and inspections. Another key aspect of my work has been ensuring proper environmental monitoring and aseptic techniques. These aren’t just checkboxes on a list; they’re critical for protecting patients from risks that might not be immediately visible. The slightest mistake can have significant consequences, so it is essential to get it right from the start. One of the biggest lessons I’ve learned is the importance of knowing your resources and setting realistic expectations. Whether you’re building a new QMS or transitioning from a legacy system, it’s a project that requires time and careful attention. Don’t hesitate to seek help when needed—whether it’s from consultants, partners, or simply leveraging your team's expertise. This journey has taught me so much, not just about the technical aspects but about the importance of planning, collaboration, and continuous improvement. If you’re in the middle of this process or thinking about making a transition, remember that every step you take towards better quality management is a step towards better patient outcomes. #GreenlightGuru
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Our team is at LSI Europe this week! ?? Excited to have Etienne Nichols, our Head of Insights & Education, moderating a panel on Sept 17, from 10:40 - 11:20 AM, diving deep into The DiGAs Framework and how HealthTech is evolving to hit the market in Europe. This is a can’t-miss session for anyone looking to stay ahead in the MedTech space! ???? And that’s not all! Dan Thompson, Chief Sales Officer, will also be session leader the same day.????? Our entire team is looking forward to meeting you at booth #1 for free swag & giveaways! #LSIEurope #HealthTech #medtech #medicaldevices #greenlightguru LSI
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We're #hiring a new Customer Support Specialist in Aalborg, North Denmark Region. Apply today or share this post with your network.
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We're #hiring a new Sr. Customer Success Manager in Indiana. Apply today or share this post with your network.
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Invest in your company's Quality Team! You won't regret it... A quality system is required, but investing in your quality team can allow them to make everyone's lives better at your company. With more budget your quality team can: 1. Hire more quality specialists to improve efficiencies of your processes across all departments. 2. Invest in an eQMS platform to increase those departmental efficiencies even more. Greenlight Guru, for example, has shown to reduce your team's time spent on development and design documentation by 50%! 3. Improve employee training to create safer medical devices for patients 4. Improve your internal auditing, and take better corrective and preventive actions to help avoid recalls, warning letters, etc. ... and much more! Investing in Quality will take your company to the next level. #quality #medicaldevices #greenlightguru
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[LIVE WEBINAR] Sept 19th @ 9 am ET/ 3 pm CET. ?? After market entry, continuous updates to the clinical evaluation are required through Post-Market Clinical Follow-Up (PMCF) under EU MDR, which involves collecting data from actual device use. By conducting PMCF, medical device manufacturers can ensure ongoing device safety and performance throughout the lifecycle. In this webinar, experts from ?????? Advanced Medical Services and Metecon GmbH will share invaluable insights into creating a robust PMCF plan and executing PMCF studies in compliance with EU MDR. Register here: https://bit.ly/3zhAuB4 #webinar #pmcf #eumdr #postmarket #medicaldevices #medtech #ggclinical #greenlightguru #live
Key Considerations for Implementing Post-Market Clinical Follow-Up for Medical Devices
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