Greenlight Guru

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Let's connect at #LSIUSA2025! Here’s how you can find our team: Pall Johannesson will be showcasing how Greenlight Guru helps to navigate regulatory challenges and streamline quality management on March 18 at 9:00 AM. Etienne Nichols is a panel moderator and will show the audience how they can access our 2025 State of the Industry Report. Schedule some time to chat with Maansi Shah, Christine Wilbert and Andy Rogantino on the LSIUSA partnering app and learn how we can help accelerate medical device companies’ path to market. Connect with the whole team and Dan Thompson at our invite-only executive dinner on March 18 from 6:00 PM to 9:00 PM (rules apply, please contact our team for eligibility).

Notification of a Manufacturing Discontinuance or Interruption: Does the FDA’s Guidance Apply to You? https://bit.ly/43kR9QG

We're #hiring - we'd love it if you shared with your network! ??

We're #hiring - we'd love it if you shared with your network! ??

Greenlight Guru is proudly sponsoring LSIUSA ‘25 again this year! We’re thrilled to continue supporting the MedTech community at one of the most influential events of the year. At Greenlight Guru, our mission is to help medical device innovators bring safer, high-quality products to market faster, and LSI events play a key role in fostering the collaboration and innovation needed to propel the industry forward. Make sure to stop by and chat with us, or book a meeting with our team members Maansi Shah, Christine Wilbert, and Andy Rogantino via the #LSIUSA25 partnering app. Get $250 off your #LSIUSA25 ticket through our link. Register here: https://hubs.ly/Q037sCsR0 We look forward to connecting!

3 Insights on MedTech Product Development from an Ex-FDA Investigator https://hubs.ly/Q037Mgyy0

Struggling with FDA submissions? One of the most common pitfalls in pre-submissions and final submissions is a poorly written device description—leading to confusion, delays, and extra testing. Join our free webinar on February 27th with Mike Drues, PhD of Vascular Sciences to learn: ? How to craft an effective device description ? The right level of detail to include ? The critical link between your labeling and device description ? How to avoid costly misunderstandings and regulatory setbacks Don’t let a weak device description derail your submission. Register now to gain expert insights and ensure FDA reviewers understand your device from the start! https://hubs.ly/Q037p3MB0

Introducing the PCCP Checklist for Medical Device Companies! Change is inevitable in medical device development, but managing it effectively is crucial. That’s why we partnered with our friends at Rook Quality Systems to develop the Pre-determined Change Control Plan (PCCP) Checklist—a structured guide to help medical device companies stay compliant with FDA guidelines while streamlining change control processes. This free tool helps teams navigate change control effectively, reducing regulatory burdens while ensuring device safety & effectiveness. Download the PCCP Checklist today and take control of your change management process! https://hubs.ly/Q037p3kr0

Regulatory shifts are coming—Is medtech ready? When the FDA is short-staffed, what happens to medical device regulations? Delays? Bottlenecks? A shift in priorities? Etienne Nichols ???, Greenlight Guru’s Head of Industry Insights & Education, recently shared his perspective in MD+DI, discussing the potential ripple effects of fewer regulators and how this could reshape regulatory pathways as we know them. ?? Will Breakthrough Devices take a hit? ?? Will 510(k) reviews slow down? ?? What must medtech companies do to stay ahead? ?? Etienne’s take: Medtech can’t afford to “wait and see.” The companies that step up, set standards, and drive best practices will define the future. Now more than ever, airtight submissions and strong regulatory expertise will separate the leaders from the laggards. Read the full piece by Amanda Pedersen in MD+DI! https://hubs.ly/Q037nWhs0