Webinars

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

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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 Ready Ideation.

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 submission data, and prepare for expected future challenges with UDI once EU MDR goes into effect.

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 Production Monitoring) to a medical device as it moves throughout the stages of the Product Lifecycle (Concept, Development, Launch, Post Market, Obsolescence).

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 this process.

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

Quality Leaders' Playbook for Driving Executive Engagement with Quality Systems

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 validation to their advantage!

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, and how manufacturers can take a proactive role in their approach.

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 development.

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.

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.

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 2020.

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.

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.

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 Case for Quality initiative and its benefits to the medical device industry.

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

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

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 equipment standards.

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 comply with ISO 13485/ 21 CFR 820/ MDSAP/ MDR regulations.

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

Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot (Part 3 of 4)

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

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

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

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 means for all stakeholders involved with the medical device industry.

Bridging User Needs & Design Requirements

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

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

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

Regulatory Intelligence (Mis)Management in the Medical Device Industry

How Software Can Be Leveraged to Streamline Device Development

Demystifying the FDA's Human Factors Guidance

What You Need to Know About Medical Electrical Standards Updates

Advanced Strategies and Tactics for Using the De Novo Pathway

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

Best Practices for Medical Device Change Management

How to Create a Risk-based CAPA Process

Top 10 Most Significant Changes Introduced by the New EU MDR

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

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 market, and help you pass audits with flying colors.

How to Prepare for a Successful Design Transfer

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

Many Connotations of Risk in Medical Device Development

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

5 Things the Medical Device Industry Should Expect in 2017

15 Steps to Get Approval to IEC 60601-1

8 Steps to Implement an EU-MDR Compliance Program

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

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

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

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

Medical Device Project Management Best Practices

Clinical Evaluation in the EU for Medical Devices

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

Everything Device Makers Need to Know About Design Controls

An Overview of ISO 14971 Risk Management

Understanding the Changes to ISO 13485:2016

How To Prepare for the Transition to ISO 13485:2016

How to Manage & Mitigate Risk in New Product Development