# greenlight.guru

> AI-optimized mirror of greenlight.guru containing 50 pages totalling 121,556 words of clean markdown content, structured data, and semantic HTML. Original source: https://greenlight.guru. Last updated: 2026-09-11T02:44:58.688Z.

Each page is available as HTML (with JSON-LD structured data) and Markdown (text-only, ideal for LLMs and RAG).

## Homepage

- [Greenlight Guru | The #1 QMS for Medical Devices](/content/site-root.html): Greenlight Guru brings modern QMS and EDC software to 1,100+ medical device companies helping improve speed and efficiency while reducing risk. (558 words)

## Articles & Blog Posts

- [blog/bridging-the-gap-avoiding-the-medtech-valley-of-death-with-dr-adam-saltman.html](/content/blog/bridging-the-gap-avoiding-the-medtech-valley-of-death-with-dr-adam-saltman.html) (743 words)
- [blog/iso-14971-risk-management/index.html](/content/blog/iso-14971-risk-management/index.html) (1,251 words)
- [Post-Market Surveillance of Medical Devices: 2026 Guide](/content/blog/postmarket-surveillance/index.html): What post-market surveillance (PMS) requires in 2026: FDA and EU MDR rules, PMS plans, PMSR vs PSUR, and best practices for device manufacturers. (5,634 words)
- [ISO Standards for Medical Devices: The Ultimate List (2026)](/content/blog/iso-standards/index.html): The 50 ISO standards medical device manufacturers need in 2026, from ISO 13485 to ISO 14971, with FDA recognition status and what each standard covers. (5,875 words)
- [Top MDCG Guidance Documents for Medical Device Companies](/content/blog/top-mdcg-guidance/index.html): Use this list of the top 30 MDCG guidance documents for medical device companies to find answers to some of the most-asked questions about EU MDR & IVDR. (3,165 words)
- [The Business Case for Integrated Design Controls](/content/blog/business-case-design-controls/index.html): 4 important aspects of design controls and how leveraging these approaches will allow you to use design controls as a competitive advantage. (1,591 words)
- [The clinical evidence investors actually care about](/content/blog/the-clinical-evidence-investors-actually-care-about.html): Statistical significance isn't the only type of significance investors care about when it comes to generating clinical evidence. Here's what else matters. (1,028 words)
- [CAPA: When to Take Corrective Action or Preventive Action?](/content/blog/capa-corrective-action-or-preventive-action/index.html): Dealing with CAPA? Here’s where you’ll use a corrective action or a preventive action. (1,290 words)
- [How Sonavex Went from Concept to FDA Clearance in Just 3 Years](/content/blog/david-narrow-sonavex/index.html): In this episode of MedTech True Quality Stories podcast, Jon Speer and David Narrow, CEO of Sonavex discuss how to successfully fundraise for seed and Series A rounds, implement a quality management system (QMS), and achieve regulatory pre-submission and 510(k) clearance.  (465 words)
- [What is a Predetermined Change Control Plan (PCCP) and Who Needs One?](/content/blog/predetermined-change-control-plan-pccp/index.html): Explaining the Predetermined Change Control Plan (PCCP) draft guidance from FDA and its significance for manufacturers with AI/ML in medical devices. (1,259 words)
- [IQ, OQ, PQ Explained: 2026 Process Validation Guide](/content/blog/iq-oq-pq-process-validation/index.html): See what IQ, OQ, PQ, and DQ prove, when each qualification applies, how to set acceptance criteria, and when requalification is required in 2026. (1,653 words)
- [Free Medical Device Templates & Checklists | Greenlight Guru](/content/free-medical-device-templates-checklists/index.html): Access a library of free medical device templates and checklists to simplify compliance, audits, and quality management activities. (927 words)
- [5 Tips to Improve your Medical Equipment Quality Assurance Activities](/content/blog/medical-equipment-quality-assurance/index.html): Five things you can start doing today to improve your medical device quality assurance activities. (1,551 words)
- [Medical Device QMS & eQMS Software | Greenlight Guru](/content/quality-management-software/index.html): Purpose-built eQMS for medical device companies. Document control, CAPA, audits, and design controls aligned with ISO 13485, the FDA QMSR, and EU MDR. (1,847 words)
- [Top Medical Device Conferences To Attend in 2026](/content/blog/top-medical-device-conferences/index.html): List of top medical device conferences taking place in 2026. (1,828 words)
- [Intelligent tools for medical device design and development | Greenlight Guru](/content/product-development-software/index.html): Accelerate your product development efforts with an end-to-end solution built to drive collaboration with Greenlight Guru's medical device product development software. (1,157 words)
- [Medical Device Document Management Software | Greenlight Guru](/content/document-management-software/index.html): Leverage our secure, digital, cloud-based document management system that gives your team the tools needed to succeed. Discover what’s possible with real traceability. (703 words)
- [How to Integrate UDI into a Quality System for Your Medical Device](/content/blog/integrate-udi-into-quality-system/index.html): Setting up a Unique Device Identification (UDI) is all about ensuring traceability quality in medical devices and in this blog we have broken it down. (1,168 words)
- [Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS](/content/blog/case-study-how-ivd-manufacturer-streamlined-production-improved-quality-processes-with-industry-specific-qms.html): How global IVD manufacturer upgraded from a paper-based QMS to Greenlight Guru's medical device QMS to streamline compliance, manufacturing and improved quality processes.  (1,621 words)
- [SaMD quality ops: Jira and GitHub in your QMS | Greenlight Guru](/content/blog/samd-jira-github-compliance-dev-stack/index.html): SaMD teams run Jira and GitHub outside their QMS and pay the audit penalty. Here is a practical six-level integration framework for closing the gap. (1,902 words)
- [Enterprise Quality Management Software: 2026 Guide](/content/blog/enterprise-quality-management-software/index.html): What enterprise quality management software is, how it differs from standard QMS software, and what medtech teams need under QMSR and ISO 13485:2016.
 (2,022 words)
- [Why Document Control Matters To Medical Device Companies](/content/blog/document-controls-medical-device-companies/index.html): Learn why document controls should be managed with an automated system that is purpose built to streamline procedures that allow teams to stay better organized, facilitate and maintain regulatory compliance, and bring safer quality medical devices to market faster.
 (1,245 words)
- [Human-Centered Design in Medical Devices](/content/blog/human-centered-design-medical-devices/index.html): In this episode, we have a thought-provoking discussion on the essence of human-centered design in medical devices and the importance of understanding user needs beyond surface-level assumptions. (952 words)
- [Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission](/content/blog/comparing-fda-submission-types-510k-vs-de-novo-vs-513g-vs-pre-submission.html): In today's episode of The Global Medical Device Podcast, Jon Speer & Mike Drues discuss the many possible FDA regulatory submission types for device markers.  (604 words)
- [Medical Device Design Control Software | Greenlight Guru](/content/design-control-software/index.html): The age of complexity and disconnect is gone. Uncover medical device design control management that keeps, innovation, quality, and traceability at the forefront. Discover what’s possible with real traceability. (748 words)
- [Medical Device Cybersecurity Standards: Best Practices](/content/blog/cybersecurity-medical-device/index.html): Explore the industry's best practices for cybersecurity in medical devices, following IEC 62304, ISO 14971 standards, and FDA guidelines. (1,520 words)
- [Software bill of materials (SBOM) for medical devices: what FDA expects in 2026](/content/blog/software-bill-of-materials-sbom-medical-devices/index.html): FDA Section 524B requires an SBOM for cyber devices. See how to generate one in CI, keep it current, and pass a 510(k) cybersecurity review. (1,532 words)
- [Centese Trades in Paper-based QMS for Greenlight Guru Quality & Achieves 510(k) Clearance](/content/blog/case-study-centese-ditches-paper-based-qms-in-favor-of-greenlight-guru-and-achieves-fda-510k-clearance.html): Choosing the right QMS is important—just ask the Centese team who after implementing Greenlight Guru’s medical device QMS software was able to streamline quality and regulatory processes to bring their device to market. (1,292 words)
- [Qualifying Your Suppliers Using a Risk-based Approach](/content/blog/qualifying-suppliers-using-a-risk-based-approach/index.html): How do you take a risk-based approach when qualifying suppliers? Start by having clear criteria and a risk-based approach across your whole business... (1,596 words)
- [Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification](/content/blog/case-study-lucerno-dynamics-has-simplified-the-13485-2016-certification-process-with-greenlight-guru.html): How Lucerno Dynamics streamlined audit prep time from weeks to hours for easy ISO 13485:2016 certification after implementing Greenlight Guru's medical device QMS software. (1,416 words)
- [Greenlight Guru AI: what we've built and where we’re headed](/content/blog/greenlight-guru-ai-features/index.html): Learn about the current state of Greenlight Guru AI: what we've built, where we're going, and why we're doing it.  (1,480 words)
- [Quality Management & QMS Consulting: What to Look For](/content/blog/quality-management-consulting/index.html): Quality management consulting services can be a huge help to MedTech companies looking to build a culture of quality. Here’s what to expect. (1,104 words)
- [Top 50 Medical Device Product Design and Development Companies (2026)](/content/blog/top-50-medical-device-product-design-and-development-companies.html): The top 50 medical device product design and development companies for 2026, ranked and profiled, plus five standout picks and how to choose the right partner. (683 words)
- [Best QMS Software for Medical Devices [Comparison & Guide]](/content/blog/best-qms-software-quality-management/index.html): Comparing the best QMS software solutions so medical device companies can make an informed decision when investing in a quality management system. (962 words)
- [Becoming a MedTech Regulatory Affairs Professional](/content/blog/becoming-a-medtech-regulatory-affairs-professional/index.html): In this episode Etienne Nichols and guest Kavetha Ram discuss how new regulatory affairs professionals can get started in a career of medical device regulations. (835 words)
- [Careers | Greenlight Guru](/content/careers/index.html): Apply to work at one of the top tech companies in the midwest, Greenlight Guru.  (529 words)
- [Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes](/content/blog/greenlight-guru-extends-platform-with-new-product-grow-to-streamline-postmarket-quality-processes.html): The only eQMS specifically for medical device will enable companies to move beyond baseline compliance to True Quality (577 words)
- [True Quality Virtual Summit | Greenlight Guru](/content/events/true-quality-virtual-summit/index.html) (754 words)
- [Greenlight Guru Expands Solution to Further Integrate Quality and Product Development Activities](/content/blog/greenlight-guru-expands-solution-to-further-integrate-quality-and-product-development-activities.html): Greenlight Guru announces Greenlight Guru Products, a new workspace and functionality to help medical device product development teams gain more control of continuous product development. (445 words)
- [SaMD: Software as a Medical Device — Classification, FDA & EU Rules | Greenlight Guru](/content/blog/samd-software-as-a-medical-device/index.html): What counts as software as a medical device (SaMD), how FDA and the EU classify it, real cleared examples, and what IEC 62304, cybersecurity, and QMSR require — updated 2026. (10,954 words)
- [Clinical Evaluation SOP Plan Template [Free Download]](/content/downloads/clinical-evaluation-procedure-template/index.html): A free template to help you get started with creating your medical device company's clinical evaluation standard operating procedure (SOP) in accordance with EU MDR 2017/745. (32 words)
- [Medical Device Product Development Checklist - Free Download](/content/downloads/medical-device-product-development-checklist/index.html): Ensure you've complied with all the design control regulations and speed up your product development efforts. (37 words)
- [Press | Greenlight Guru](/content/press/index.html): Greenlight Guru In the News. Discover the latest and greatest from Greenlight Guru by exploring our press resources. (4,301 words)
- [Guide to Bringing a Medical Device to Market [GTM Strategy]](/content/blog/bringing-medical-device-to-market/index.html): A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets. (14,878 words)
- [Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru](/content/blog/index.html): Explore insights, best practices, and resources in the MedTech industry, focusing on clinical evidence, regulatory compliance, and quality management for medical device professionals. (10,676 words)
- [Writing a Clinical Investigation Plan Checklist - Free Download](/content/downloads/clinical-investigation-plan-checklist/index.html) (57 words)
- [Abbreviated 510(k) Submission Checklist - Free Download](/content/downloads/abbreviated-510k-submission-checklist/index.html): Want to make sure you’ve included all of the necessary sections in your Abbreviated 510(k) submission to FDA? This free downloadable checklist can help. (29 words)
- [Top 100 Medical Device Companies [+Downloadable List]](/content/blog/top-100-medical-device-companies/index.html): We've gathered the ultimate list of the top 100 medical device companies including their total revenue, market cap, and R&D spend.  (11,967 words)
- [ISO 13485 Explained: Medical Device QMS Requirements (2026)](/content/blog/iso-13485-qms-medical-device/index.html): Every ISO 13485:2016 requirement, what certification actually involves, and how the standard became the backbone of FDA's QMSR. Updated August 2026. (11,113 words)

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