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) development phases.
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 pathways, discuss relative timelines and costs as well as the importance of clinical data, and other relevant topics.
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 ways to easily and effectively transition to compliance with the new requirements.
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 device.
A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for regulatory submission and sales, with minimum burden on budgets and schedules.
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 decision-making and improvements to made throughout the change process.
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 specialties.
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 challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry standards and regulations, and the strategies, tactics, and tools device professionals can use to achieve truly connected quality.
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, develop, manufacture and market are safe and effective.
A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can prepare accordingly.
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 approaching and communicating with FDA.
A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, production and postproduction monitoring) as a product moves through the product lifecycle (concept, development, launch, postmarket, obsolescence).
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 competition.
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 medical device.
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 leading up to your regulatory submission.
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, and must-know takeaways device makers need to know.
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 effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.
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 documentation.
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 24971:2020.
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 well as creative ways to use post-market surveillance to their advantage!
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.
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.
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).
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.
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!
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.
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.
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 2020.
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 Case for Quality initiative and its benefits to the medical device industry.
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.
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.
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.
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.