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MedTech Lifecycle Excellence Platform

The solution that powers end-to-end product lifecycle excellence from idea to commercialization to postmarket surveillance.

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State of Medical Device Industry 2022

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Free Webinars

Free training webinars to help you keep up with medical device regulatory changes and achieve true quality.

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Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device

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 ...

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Bridging the Gap Between Development and Regulatory Teams

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, ...

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How to Survive an FDA Inspection

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 ...

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Special Controls: What Are They & How Can We Use Them To Our Advantage?

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 ...

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How to Proactively Predict & Mitigate Risk throughout the Supply Chain

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 ...

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Top Things You Should Know When Developing Software as a Medical Device (SaMD)

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 ...

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Key Pitfalls To Avoid In Medtech Clinical Data Collection

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 ...

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Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?

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 ...

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Is Regulation Necessary for Quality? How to Improve Your Product & Bottom Line with Compliance & a QMS

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.

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Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability

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 ...

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UDI Product Data and EUDAMED, Get Onboard!

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 ...

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How to Ace your Internal Audits in 2022

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, ...

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How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File

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.

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Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

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 ...

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Breakthrough Device Designation & Its Impact on Reimbursement

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 ...

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The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?

A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).

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The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and ...

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Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

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 ...

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Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers

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 ...

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Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

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 ...

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5 Key Points to Consider in Design Transfer of Medtech

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 ...

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10 QMS Musts for SaMD and Devices Featuring Software (and how to best utilize for product & team success)

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) ...

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FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

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 ...

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Attention ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update your Medical Device Labeling to Comply with the New Requirements

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 ...

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Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?

Free interactive webinar exploring ...

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How to Prepare for and Manage Audits/Inspections across Global Markets

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.

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Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical ...

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How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for ...

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3 Ways to Transform your Change Process through AI-powered Predictive Quality

A free, in-depth webinar explaining how to transform the change management process from reactive to predictive quality through AI/ML technologies that enable proactive ...

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Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

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 ...

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When Do We Need FDA’s Permission to Market Our Device and When Do We Not?

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.

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3 Powerful Ways to Revolutionize Your Approach to Closed-Loop Quality System Traceability

A free, in-depth webinar covering the challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry ...

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Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

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.

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How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

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, ...

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Insider’s look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can ...

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Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

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.

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Understanding the Medical Device Classification System: From Basics to Beyond – Using Classification to your Competitive Advantage

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 ...

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How to Integrate Risk Management throughout the Lifecycle of a Medical Device in the Coming Decade

A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, ...

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3 Ways Medical Device Companies Working Remote Are Leveraging QMS Software To Foster Innovation And Collaboration

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 ...

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How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic?

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.

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Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?

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 ...

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How to Use UX to Streamline Medical Device Product Cycles

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 ...

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Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.

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Behind the Stats: Medical Device Product Development & Quality Management Benchmark Survey

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, ...

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Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent

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 ...

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Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

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 ...

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An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

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 ...

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Post-market Surveillance For Medical Devices And Combination Products: If A Device Is Fda Cleared Or Approved, Can We Assume It’s Safe And Effective?

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 ...

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How and When to Start Documenting your Formal Design Controls with DHF Ready Ideation

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 ...

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How And When To Register EU Medical Devices And Report UDI Information To EUDAMED

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 ...

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How To Apply Risk Management Throughout The Product Lifecycle Of Your Medical Device

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 ...

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10 Steps To Preparing Your 510(k) Submission (And How To Avoid The Common Pitfalls)

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 ...

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Breakthrough Designation Program: Is This An Option For My Medical Device?

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Why Design Validation is More than Testing: How do we validate our validation?

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 ...

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Understanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive

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, ...

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Why User Needs Matter & Their Benefits in Streamlining Device Design and Development

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 ...

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UX for Medical Devices: Designing for the Evolving Environment of Technology, Safety, Regulation and Recalls

A free webinar on the ways in which UX design can mitigate human error while reducing both recalls and product development costs.

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How to Avoid Common Problems with your Design, Risk, and Validation Documentation

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.

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Prepping your QMS for EU MDR

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 ...

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When Design Input Requirements Go Wrong

A free webinar on what happens when Design Inputs, which are widely regarded as the most important design control element, go wrong.

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EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

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.

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FDA Partners with Greenlight Guru: Case for Quality Webinar Series

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 ...

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The 510k and Substantial Equivalence: Why do so many get it wrong?

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5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process

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Standards, Standards, Standards – Makes the Medical Device World go Around

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 ...

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How to Conquer Supplier Management for Medical Device Companies

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 ...

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FDA's Case for Quality: Non-Product Computer System Validation (Part 4 of 4)

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The Pre-Market Approval (PMA): Is it really as bad as so many think?

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FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)

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10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR

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FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm

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 ...

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Bridging User Needs & Design Requirements

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A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

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General Wellness Devices & Wearables: Regulatory Options You Need to Know

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5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

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Regulatory Intelligence (Mis)Management in the Medical Device Industry

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How Software Can Be Leveraged to Streamline Device Development

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Demystifying the FDA's Human Factors Guidance

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What You Need to Know About Medical Electrical Standards Updates

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Advanced Strategies and Tactics for Using the De Novo Pathway

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How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAs

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Best Practices for Medical Device Change Management

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How to Create a Risk-based CAPA Process

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Top 10 Most Significant Changes Introduced by the New EU MDR

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How to Prepare for the Medical Device Single Audit Program (MDSAP)

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How QMS Software Can Speed Up Your Product Development & Simplify Compliance

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 ...

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How to Prepare for a Successful Design Transfer

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How to Prepare for (and Make the Most of) Your FDA Pre-Submission

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Many Connotations of Risk in Medical Device Development

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What You Need to Know About Life with FDA After Your Device Gains Clearance

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5 Things the Medical Device Industry Should Expect in 2017

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15 Steps to Get Approval to IEC 60601-1

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8 Steps to Implement an EU-MDR Compliance Program

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How to Prepare for the New EU Medical Device Regulations (MDR)

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How to Simplify Your Compliance to the New ISO 13485:2016

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How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

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510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer

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Medical Device Project Management Best Practices

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Clinical Evaluation in the EU for Medical Devices

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How To Avoid and Respond to FDA 483's and Warning Letters

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Everything Device Makers Need to Know About Design Controls

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An Overview of ISO 14971 Risk Management

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Understanding the Changes to ISO 13485:2016

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How To Prepare for the Transition to ISO 13485:2016

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How to Manage & Mitigate Risk in New Product Development

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