More than a Quality Management System: Tools for the entire MedTech Lifecycle.
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Accelerate development with integrated design control and risk software.
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Data collection and management designed for MedTech clinical trials.
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Free training webinars to help medical device professionals keep up with industry best practices, navigate regulatory changes, and achieve True Quality.
In this webinar, experts from TÜV SÜD and Greenlight Guru will explore examples of PMCF methods. Sign up to get a better understanding of PMCF.
This live demo offers a look into how our Training Management software, specifically new functionality enhancements to simplify training administration tasks that significantly ...
This webinar provides an in-depth overview of the QMSR final rule, how FDA responsed to the proposed rule comments, and how it may impact the MedTech industry and FDA. Particular ...
Free, in-depth webinar to guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for any medical device manufacturer planning a 510(k), De Novo, or PMA ...
Register for this webinar to learn about significant risk vs. nonsignificant risk, including best practices to avoid timely, costly mistakes and creative ways to use the SR and ...
This live demo session will showcase the new Reporting module from Greenlight Guru Clinical, emphasizing its role in streamlining clinical data management for the MedTech ...
Live demo showing how our Risk Management software aligns with ISO 14971:2019, ensuring compliance and fostering collaboration for enhanced product safety, accelerated ...
Join us for this enlightening webinar where we will delve into critical insights and strategies essential for MedTech professionals involved in outsourcing or insourcing clinical ...
Kick off 2024 with an exclusive look into the latest advancements and upcoming innovations at Greenlight Guru, unveiling what’s new, what’s coming, and what’s next for the future ...
In this live demo session, gain insights into Greenlight Guru Clinical's fully optimized functionality for a diverse range of clinical studies and RCTs.
Live demonstration of how to conduct audits with ease and achieve real-time readiness using Greenlight Guru Quality, the leading QMS software for MedTech.
Free webinar presented by FDA covering key highlights and updates from the final pre-market guidance to help MedTech companies prepare for the requirements.
Live demo of Greenlight Guru Quality showing how to drive efficient, risk-based product development and quality management while simultaneously driving traceability throughout the ...
Live demo addressing key challenges faced by clinicians and distributors in obtaining post-market surveillance feedbac, and exploring best practices for successful clinician ...
This free webinar provides the tools and knowledge you need to master your next medical device audit, including specific areas to focus on during the audit preparation, how to ...
To pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning. Watch this webinar to learn ...
How do you ensure that clinical data is collected in line with your study goals while taking the clinical workflow at the study sites into account? Watch this webinar, to find ...
Subject recruitment in clinical studies is one of - if not the biggest - cause for delay in clinical study timelines. In this webinar, you will learn some of the best practices to ...
Learn how to leverage quality and compliance for better financial outcomes in the MedTech sector in this webinar.
Free webinar designed to guide medical device companies through the process of upgrading their Quality Management System (QMS) efficiently.
In this session we will examine some of the common study recruitment models and how each model enables sponsors to maximize recruitment efficiencies. We will also take a look at ...
This webinar will provide you with insights on how comply with the General Safety and Performance Requirements (GSPR) of the EU Medical Device Regulation (EU MDR)
During this webinar we will focus on how to collect relevant clinical data to support market claims in an analytical way and align you with authorities' expectations.
Live, guided demonstration of eCRFs in Greenlight Guru Clinical, the leading software for MedTech clinical data collection.
Actionable webinar to help participants learn best practices for complaint handling to avoid timely and costly mistakes as well as creative ways to advantageously manage ...
Informative webinar where FDA regulatory expert Eric Henry provides an overview of the QMSR proposed rule, explains next steps in the rule-making and implementation process, and ...
This panel session offers a unique opportunity to delve into the nuances of monitoring and data management to learn how to navigate the challenges these crucial areas present. ...
Join us and discover best practices to validate an EDC system as well as your study setup to avoid discrepancies, compliance issues and ensure data integrity and accuracy.
Informative webinar where participants will learn how to confidently navigate the complexities of FDA cybersecurity requirements and enhance medical device submission strategies.
Free webinar presenting proven techniques and tips for medical device companies to prepare technical documentation per Annex II and Annex III of EU MDR, as well as ways to respond ...
Free webinar for medical device professionals to gain the knowledge and strategies necessary to successfully implement IEC 62304 to ensure compliance, while developing superior ...
Free webinar providing an update on global UDI regulations, including FDA initiatives to improve GUDID data quality and the recent EU Legacy Device Amendment, as well as UDI ...
This free webinar will help medical device companies understand the regulatory expectations for substantial equivalence and how to successfully demonstrate it in all types of ...
This free webinar covers 10 of the most important factors to consider when designing the optimal eCRF for clinical investigations.
Free webinar providing valuable insights and proven best practices in three key areas defined in this recent study: improving organizational efficiencies, mitigating risk, and ...
This free webinar will provide best practices and actionable tips for MedTech companies to effectively manage Risk across the entire medical device lifecycle.
In this free webinar, you’ll get a chance to hear from a hospital executive, a MedTech sales leader, and MedTech startup “nerd” as they discuss strategies for navigating the ...
This free webinar presented by Jon Bergsteinsson, SMART-TRIAL by Greenlight Guru co-founder, and Autumn Lang, PhD, RAC, Director of Clinical Affairs at VeriSkin Inc. covers ...
Jon Bergsteinsson and ISO14155 SME Maria Nyåkern will discuss strategies to successfully fulfill GCP requirements for medical device companies.
This free webinar presented by MedTech industry expert, Barret Mueller, to learn what a modern QMS is and what medical device companies should be looking for in a QMS solution.
During this webinar we will review the available RTA checklists and participants will learn how to design a submission that will pass administrative review and avoid receiving an ...
In this webinar, leading MedTech experts from QServe and SMART-TRIAL by Greenlight Guru share their insights on alternatives to PMCF clinical investigations and suggest ways ...
This free webinar provides a "how to" for DHF/TF and RMF creation for both SaMD and hardware devices.
This webinar will highlight why MedTech companies should be concerned about what tools they use to maintain traceability - from an economical, regulatory, and ethical standpoint, ...
Free webinar covering the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with regulatory stakeholders on first hand ...
In this free webinar medical device experts from Avania and SMART-TRIAL by Greenlight Guru share advice and insights on how medical device manufacturers can optimize clinical ...
In this free webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, teams up with CEO of Evnia, Efstathios Vassiliadis, to present you with a simple, yet powerful tool, to collect ...
This webinar will answer the most common questions on eConsent in medical device clinical investigations, with Jon Bergsteinsson and Pall Johannesson co-founders of SMART-TRIAL by ...
Register for this free webinar presented by clinical data expert and co-founder of SMART-TRIAL by Greenlight Guru, Páll Jóhannesson, and senior director of clinical operations at ...
This free, in-depth webinar, presented by regulatory experts Kevin Go and Allison Komiyama, will discuss recent regulatory developments in the Digital Health space, how to apply ...
In this free, interactive webinar industry expert Michael Drues, PhD, explains what regulatory due diligence is for medical device professionals and how to do it, as well as how ...
Join us for a live webinar as industry experts Shawnnah Monterrey, CEO of BeanStock Ventures, Kate Burns, Senior Software Product Manager at Arthrex, and Chris DuPont, CEO of ...
Free, educational webinar covering pertinent details and established best practices on how to prepare your QMS, technical, and clinical documentation for the upcoming IVDR ...
In this free, in-depth webinar, Satyajit ‘Sat' Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and ...
This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will use actual devices as case studies to take a critical look at the way we do ...
Join Proxima Clinical Research’s subject matter expert, Director of Regulatory Affairs, Isabella Schmitt, MBA, RAC, who will expand on clinical considerations for software and ...
Register for this free, in-depth webinar where Carlos Almeida, District Manager & Vice President, Engineering at SPK and Associates, will walk you through how to manage electronic ...
Register for this free, in-depth webinar as we discuss how State of the Art, in context of the formal MDR and MEDDEV references, impacts Technical Documentation, Risk Analysis, ...
Register for this free webinar presented by Abbas Dhilawala, CTO of Galen Data, who will describe these challenges and provide considerations that are critical for success.
Register for this free, in-depth webinar presented by Rook Quality Systems Sr. Quality Manager Chandler Thames who will expand on the new MDR requirements, and provide key ...
A free, in-depth webinar covering integrating cloud and other modern computing technologies into the operation of medical devices and what cloud computing can teach us about the ...
A free, in-depth webinar covering the intersection and friction between development and regulatory teams, with a focus on remedies in the form of processes, tools and approaches, ...
A free, in-depth webinar covering some preventative actions that a medical device company can take to minimize the possibility of receiving a 483 which in some cases could result ...
This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will cover the basics of special controls, how to know if your device needs them and ...
A free, in-depth webinar covering proactive strategies for predictive risk mitigation throughout the supply chain based on core principles of Risk Based Methodologies as it ...
A free, in-depth webinar presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to ...
A free, in-depth webinar presented by clinical data experts Páll Jóhannesson and Jón Bergsteinsson from SMART-TRIAL who will help you avoid common pitfalls that make your ...
A free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, covering the basics of how to prepare a letter-to-file the right way in order to avoid a ...
A free, in-depth webinar exploring how regulations and standards contribute to the improved safety and overall quality of medical products and directly affect cost and profit.
A free, in-depth webinar exploring a more efficient process to control and collaborate on product development to streamline work for faster submissions and continuous ...
A free, in-depth webinar covering best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming ...
A free, in-depth webinar explaining how to conduct internal audits of core QMS functions and cross-functional collaboration methods you can use to benefit your product, QA/RA, ...
Free, in-depth webinar covering various key changes to ISO14971 and practical approaches for implementation of the new standard for both new products and legacy products.
A free, in-depth webinar covering the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and ...
A free, in-depth webinar covering the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to ...
A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).
A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and ...
A free, in-depth webinar covering what to expect and do for a successful clinical trials program and market launch for Non-significant Risk (NSR) devices, IVDs, Software as a ...
Free, in-depth webinar covering the human factors engineering process and how to comply with the applicable regulatory requirements of the US, UK, EU, and other international ...
A free, in-depth webinar covering BDD and STeP application processes and why getting these designations early in the regulatory process can help clear a device’s pathway to ...
Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at ...
A free, in-depth webinar covering the best practices for setting up an agile QMS which can be adapted and optimized concurrently with software as a medical device (SaMD) ...
Free, in-depth webinar presented by regulatory experts from the Greenlight Guru Regulatory Advisory Board, where they will compare and contrast FDA versus EU regulatory ...
This free, in-depth webinar will cover the latest updates of ISO 15223-1 4th Edition to help participants understand the full scope of changes and uncover actionable ...
Free interactive webinar exploring ...
In this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections.
A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical ...
A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for ...
Free interactive webinar demonstrating how to integrate change management and risk management and will share best practices using case studies from a variety of clinical ...
A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.
A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.
A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, ...
A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can ...
A free in-depth webinar covering the most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.
A free, in-depth webinar covering the medical device classification system and how companies can use it to their competitive advantage by using best practices for ...
A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, ...
This free in-depth webinar will cover how companies using turn-key, best-in-class QMS software are able to remain agile in order to innovate and outperform the ...
This free in-depth webinar will explore the Emergency Use Authorization — specifically in the context of COVID-19 — and how medical device companies can use it.
This free in-depth webinar will explore all regulatory pathways to market — including the lesser-known and lesser-used ones — to help you decide which to use when for your ...
A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle ...
A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.
A free in-depth webinar on industry benchmark survey findings of over 500 medical device professionals around the globe, covering the most compelling stats, biggest surprises, ...
A free webinar covering the design control “framework” and recommendations to effectively meet their requirements. Emphasis will be placed not only on regulatory aspects but on ...
A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and ...
A free, in-depth webinar covering the new changes to ISO 14971:2019, the international standard for medical device risk management, and its companion guidance document ISO TR ...
In this free webinar participants will learn post-market surveillance best practices for medical devices and combination products to avoid timely and costly mistakes, as ...
In this free webinar participants will learn how and when to start formal design controls to improve product development through an innovative and proven approach known as DHF ...
In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI ...
In this free webinar participants will learn how to apply Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post ...
In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during ...
In this free webinar participants will learn best practices for design validation, including how to avoid timely and costly validation mistakes and creative ways to use ...
A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, ...
A free webinar about connecting empathy and purpose to gain meaningful user insights that translate into optimal design inputs and product quality in medical device ...
A free webinar on the ways in which UX design can mitigate human error while reducing both recalls and product development costs.
A free webinar on the simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk and systemic issues.
A free webinar on the critical steps that are needed in order to prepare your Quality Management System (QMS) for the upcoming EU Medical Device Regulations (EU MDR) in ...
A free webinar on what happens when Design Inputs, which are widely regarded as the most important design control element, go wrong.
Free webinar on how to interpret European Union’s Medical Device Regulation (EU MDR), what it means to each organization, and what you can do to be compliant in the EU.
Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's ...
Free webinar presented by the FDA and Greenlight Guru. Learn about IMDRF, its forthcoming guidance, and how its priorities play in relation to international medical electrical ...
Free webinar presented by Kyle Rose of Rook Quality Systems and Greenlight Guru. Learn to conquer supplier management by updating your processes and using best practices to ...
Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this ...
Learn how modern, purpose-built software not only ensures you compliance with all the latest regulations but also frees up your engineers’ time, reduces risk, speeds time to ...