Greenlight Guru

The medical device development journey is complex, so understanding its five key phases is essential for success: 1. Initiation, Opportunity, and Risk Analysis Begin with thorough planning and research. Establish a robust quality management system (QMS) to ensure compliance and set a solid foundation. 2. Formulation, Concept, and Feasibility Develop and test your concept. Engage with potential users to gather feedback, ensuring the device addresses real needs and is technically viable. 3. Design & Development, Verification & Validation Create prototypes and rigorously test them. Ensure the design meets all requirements and functions as intended under real-world conditions. 4. Final Validation and Product Launch Preparation Prepare for market entry by finalizing marketing strategies and ensuring all regulatory requirements are met. Accurate and evidence-backed claims are crucial. 5. Product Launch and Post-Market Activities Introduce the device to the market and monitor its performance. Collect post-market data to inform future improvements and ensure ongoing compliance. By diligently following these phases, medical device companies can streamline development, mitigate risks, and deliver products that enhance patient care. For a comprehensive guide on this process, explore our detailed article: https://bit.ly/493oMra

We're excited to unveil Greenlight Guru Clinical's 2024.2 update to it's Consent Package! What's included: 1?? Explicit Consent - More Compliance, Less Paper Subjects can now tick boxes directly within the consent PDF, selecting optional aspects of the study. For regions like the UK, where explicit consent is mandatory, this feature meets stringent regulatory needs while enabling a paperless workflow. Fully digital and customizable checkboxes adapt to your unique study requirements. 2?? Fully Automated Consent Flow = Effortless Workflows Participants can self-enroll, complete inclusion/exclusion steps, consent, and start questionnaires—all without manual intervention. This eliminates repetitive manual tasks for research coordinators, freeing them to focus on study quality rather than logistics. Participants enjoy a seamless, self-driven process that keeps engagement high. 3?? Customizable Public Sign-Up (think, flexibility to fit your study) Toggle different sections on or off, such as information text, simple consent (e.g., data processing agreements), investigator attributes, or subject information. Every study is unique, and this feature adapts to match. Whether it’s a data consent checkbox or detailed subject information, you control what’s shown. Precision personalization for diverse protocols. 4?? Single Signature Option: Digitization Made Simple Removes clinician counter-signature for low-risk studies, streamlining the consent process entirely. Perfect for low-risk studies - this feature reduces administrative overhead. By removing counter-signatures, you speed up consent collection and ensure participants can move forward without unnecessary delays. Every feature in 2024.2 was designed to meet the needs of real-world studies, from addressing UK-specific regulations to optimizing workflows globally. The result? Fewer bottlenecks, more engagement, and better compliance. This is more than just a feature update—it’s a smarter way to run trials. Check out more here: https://bit.ly/3OkNdqq Which of these features will impact your studies the most? Let’s talk about how 2024.2 can help! #ClinicalResearch #Innovation

We’re in the final stretch, and the response has been incredible! ?? If you haven’t yet contributed to the 6th annual MedTech Industry Benchmark Survey, there’s still time to share your perspective. What’s shaping the future of MedTech? Where are the biggest opportunities? How do we solve the challenges ahead? Your insights play a crucial role in shaping what’s next for our industry. Don’t miss your chance to add your voice to the conversation. Use this link to take the survey before it closes! https://bit.ly/4fGzBSv #MedicalDevices

In an industry where precision and innovation are everything, having the right insights at your fingertips makes all the difference. Our Resource Hub is here to empower medtech professionals with: ? Latest Regulatory Guidance ? Expert Webinars & Podcasts ? Industry Insights & Whitepapers Whether you're scaling compliance, improving quality management, or pioneering cutting-edge devices, we've got you covered. Explore now and elevate your expertise: https://bit.ly/3CusspC

How much clinical data is enough for EU compliance? Too many MedTech companies overdo it and waste resources. Others fall short and face non-compliance. Join us on November 19, 2024, at 9:00 AM ET for a webinar that cuts through the noise. ? Navigate EU regulations with clarity. ? Understand when clinical data is truly needed. ? Optimize your compliance strategy to avoid costly mistakes. Featuring insights from: ?? Bassil Akra from AKRA TEAM ?? Chris Rush from Greenlight Guru Register now to make informed decisions and strengthen your compliance game. https://bit.ly/48QIy9h

The True Quality Roadshow 2024 was a whirlwind of connection, insight, and innovation. From coast to coast, we saw the MedTech community come together to share knowledge, challenge norms, and pave the way for a better industry future. Thank you to all who came out and made the 2024 True Quality Roadshow what it was! A massive shoutout to our incredible partners who made this journey possible: CS Lifesciences, Rook Quality Systems, & CLEIO. Your support and collaboration were at the heart of every conversation and breakthrough. ?? As we look back on a phenomenal year of learning and connection, we're also gearing up for what’s next. While 2025 plans are still in the works, one thing is certain – we’re more excited than ever to continue building bridges with this amazing community. Stay tuned. The future of MedTech is only just getting started. ?? #TrueQuality #MedTech #GreenlightGuru

Have you heard of the FDAs "Predetermined Change Control Plan (PCCP)? Where companies used to have two options for post-market changes - Letter to File, or additional submissions (usually in the form of a PMA or a Special 510k) - there is a new way to change your device... Provided you've planned for this change well in advance. It's called the PCCP. A PCCP typically includes three main components: 1. Description of the planned modifications, 2. Modification protocol outlining how these changes will be validated and implemented, ? 3. An impact assessment to weigh benefits and risks and mitigate them. If you're interested in learning more, we're bringing Michael Drues in to discuss this topic this Thursday, November 14th at 1pm EST. We hope to see you there! https://lnkd.in/eUuh-uss

One week in, and the response has been incredible! ?? Our 6th annual MedTech Industry Benchmark Survey is off to a strong start, but we still need your unique insights. What trends are reshaping MedTech? Where do the biggest opportunities lie? How do we tackle the most pressing challenges together? This is your chance to influence what 2025 could look like for our industry - join the conversation and make your mark! Be part of the collective wisdom. The MedTech community wants to hear your voice. ?? https://bit.ly/48EnPVU #MedicalDevices

In case you missed it - we have a webinar coming up later TODAY with Kapstone Medical! When is it? ?? Nov. 7th, @ 1pm - 2:30pm EST Who is it for? ?? Quality & Regulatory professionals, Product Development engineers, Project Managers, and Executives involved in the development of a medical device. What is it? ?? The holy grail of medial device product development - a way to ensure your medical device development is headed in the right direction, from the very beginning. Title: The Importance of Integrating Regulatory Early into Product Development. Be sure to come with questions! https://bit.ly/40zs82U P.S. Will I see you there??

?? IVD devices are transforming healthcare diagnostics, from early detection to personalized treatment—and staying compliant in this space is critical. In Greenlight Guru’s Ultimate Guide to In Vitro Diagnostic (IVD) Devices, we dive into everything IVD manufacturers need to know for successful market entry and regulatory compliance: ? Classification Standards: Understanding the risk classes for IVDs in both the U.S. (e.g., Class I, II, III) and Europe under the IVDR. ? Regulatory Pathways: Key routes like 510(k) and PMA in the U.S. and IVDR compliance in Europe to ensure patient safety and efficacy. ? Laboratory-Developed Tests (LDTs): A look at how evolving regulations could impact LDTs and why this matters for labs. For any IVD company, building robust quality management and regulatory strategies isn’t just about compliance—it’s about elevating patient outcomes. Dive into our guide for insights that keep you informed and compliant. ?? https://bit.ly/4fcRt7p