Greenlight Guru

What are Design Outputs? 💡 In MedTech, Design Outputs are the blueprint of the device. They're the end result of the Design Inputs – after engineering has turned all of those inputs into a functioning device complete with assembly drawing, you have Design Outputs. In this short video, Etienne Nichols discuses the differences nad shares a few examples of design outputs and inputs. Was this helpful for you? Let us know in the chat, and if you got any questions leave a comment. #designoutputs #designinputs #productdevelopment #engineering #videos #greenlightguru #medtech #medicaldevices

We are thrilled to share that Greenlight Guru has achieved SOC 2 Type II compliance! 🚀🎖️ This significant milestone underscores our unwavering commitment to best-in-class security controls, ensuring our customers' data protection. In addition, we are proud to have maintained our ISO 9001 and 27001 certifications. 🔥 By leveraging our purpose-built QMS software, we continue to uphold the highest quality and security standards. Our annual reports, validated by an independent auditor, guarantee that our customers can have full confidence in the safety of their data with us. Learn more about our QMS and how it helps MedTech streamline processes and regulatory compliance. https://hubs.ly/Q02HXgnr0 #soc2 #certification #greenlightguru #ggquality #iso9001 #27001 #security #qualitymanagement #qms

Know anyone that’s developing a medical device? Because they need to know about our 2024 MedTech Path to Market, True Quality Summit Series. (Listen, I didn't come up with the title... 😅) This is a free, 3-day event with 10 sessions... The presenters include ex-FDA submission reviewers, product development engineers, and QA/RA professionals who've seen it all. (But don’t tell anyone, my favorite part is getting to chat with y’all...) And because it's my favorite part, we've decided to award prizes for the attendees that embody our values: True Quality, Fanatical Support, and Be Innovative (But Etienne, how are you going to determine who embodies those values ?) I'm still working on that part... So let me just reserve the right to change what the awards are for right now!! Let's use the format we’re used to for our kids birthday parties: 𝗪𝗵𝗮𝘁: Free 3-day virtual event where we simplify Quality Management, Design Controls, Risk Management, and Regulatory pathways. 𝗪𝗵𝗲𝗿𝗲: Wherever you are in the world that has an internet connection! 
 𝗪𝗵𝗲𝗻: August 6 - 8, 2024 𝗪𝗵𝘆: It’s more than great information - it’s a chance to interact with some of the greatest minds in MedTech and ask them questions that are relevant to what you're doing.
 Now you can save this post and not worry about remembering! (Hmm, unless you're like me and can never remember how to find saved LinkedIn posts...) You know what, I’m just gonna break the rules and give you the link: https://lnkd.in/gC9nzPZs 😅 If you know someone working in medical devices that this could benefit, feel free to share!. P.S Which one of GG's values is your favorite? (Be innovative, True Quality, Fanatical Support) Put it in the chat! 🙌

The European MDR and IVDR have shifted focus to ongoing clinical evaluation and performance assessment. Today's featured blog post examines: 💡 Importance of target population selection 💡 Balancing inclusion/exclusion criteria 💡 Collaboration between manufacturers, clinicians, and CROs This is how these factors impact study design and regulatory compliance: https://hubs.ly/Q02HBdBP0 #ivdr #mdr #medtech #medicaldevices #clinicalevaluation #riskmanagement #performancestudy #greenlightguru #blog

In today's featured episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They dive into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. 🤕 The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes. 🗣️ 🎧 Here's the full episode: https://hubs.ly/Q02HBd9k0 #podcast #medicaldevicepodcast #medtech #medicaldevices #fda #wounddressing #rule #regulatory #greenlightguru

📍 MedTech Path to Market Virtual Summit, August 6-8th📍 You know you want to join. Here's why 🔥 What is it? Free virtual summit designed to support you in bringing a medical device to market all the way from product development to regulatory submissions. Any hot topics? Plenty. 🤩 🌠 Design Controls and QMSR 🌠 Intended Use, indications for use 🌠 PMA, 510(k) & De Novo 🌠 EU MDR technical documentation, clinical evaluation and audits and many more... Expert speakers? Absolutely! 💪 Kyle Rose, Peter Sebelius, Allison Komiyama, PhD, RAC, Ben E., Adnan Ashfaq, Helene Quie, Eric Henry, and so on. What's in it for me? 🤔 On top of free, expert insights and strategies, you get to participate in fun activities and engage with industry leaders and fellow professionals throughout the entire event. 🎲 🏆 Make a friend, win a prize (or 2, or 3) and help us foster a sense of belonging and community in MedTech. 👥 Who knows when there'll be a global glitch again 😳, so go register while you still can: https://lnkd.in/dz469csE #medtechpathtomarket #premarket #medicaldevices #medtech #virtualsummit #productdevelopment #quality #regulatory #greenlightguru

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The ongoing debate... Design Inputs vs. User Needs 🤯 Design Inputs are the technical, objective requirements that a device must meet. 🤔 These translate the user needs into measurable, specific criteria like: 📍 Dimensional limits 📍 Power requirements 📍 Heating/cooling specs, etc. User Needs on the other hand, are the subjective desires of the people actually using the device. ✨ They describe the user's perspective like: 📍 Ease of use 📍 Portability 📍 Time for procedures, etc. Confused? Here's a specific example from our very own Etienne Nichols. If this has been helpful for you, like & share! 💚 Have questions? Drop them in the comments. 👇 #video #designinput #userneeds #productdevelopment #quality #greenlightguru #medtech #medicaldevices

We're doing it again! #livewebinar with FDA and ISACA✨🔥 📅 August 1st, 1 pm EST/ 7 pm CEST. Sign up to learn about the VIP program and how fostering a culture of quality is essential in MedTech. 👇 Join us for an exclusive webinar to hear directly from FDA and ISACA experts about how you can become one of the top-performing device makers by leveraging the VIP. You'll learn how the program can help you enhance quality standards, improve manufacturing processes, and achieve optimal business outcomes. Register now: https://hubs.ly/Q02H39Fm0. #medicaldevices #vip #medtech #webinar #greenlightguru #fda