- Why Us
2023 was a busy and exciting year here at Greenlight Guru. Over the past 12 months, we’ve been listening closely to our customers, innovating our products, and winning industry accolades along the way.
What does that look like? Well, in 2023, we:
We brought all our purpose-built solutions under one umbrella: The Greenlight Guru MedTech Suite.
We released Risk Solutions—an AI-powered, first-of-its-kind complete risk management software for MedTech.
We took Greenlight Guru Quality from a closed system to a connected one with the introduction and continued release of our APIs.
And much, much more! If you want to see the rest, check out our 2023 Year in Review blog post to get the full picture of what we were up to in 2023.
One thing that isn’t new this year, however, is our commitment to putting out the most insightful, informative, and comprehensive content in the MedTech industry. We write, record, and host an enormous amount of content for you throughout the year, which is why we’ve taken the time to look back, find our most popular content, and present it here for you.
There’s something in this list for everyone, so check it out and enjoy!
The Greenlight Guru Medical Device Blog provides actionable tips, best practices and insights for better medical device quality, compliance and product development. Join 200,000+ other MedTech professionals outperforming their peers by subscribing to our newsletter.
Comprehensive overview of postmarket surveillance (PMS) of medical devices, covering the different regulations and providing best practices and tips for carrying out PMS activities.
Medical device clinical trials can happen at different points in a device lifecycle. This blog post covers what you need to know about study types and regulatory pathways.
A look at what process verification and process validation refer to, and when you should use each of them in medical device manufacturing.
dFMEA and ISO 14971 offer different approaches to medical device risk management, but they can be used together. This article explains how to do it.
Become familiar with ISO 14155:2020 in this comprehensive guide, so you can conduct a well-executed clinical investigation for your medical device that yields optimal results.
Explaining the FDA human factors guidance draft to help medical device companies understand the regulatory guidelines and how it could impact their business.
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.
A QMS audit doesn’t have to be an ordeal. This blog explains how to prepare for your next external or internal audit/inspection.
Computer software assurance is the new approach to software validation in MedTech. This blog post explains how it differs from computer system validation.
Electronic data capture (EDC) systems are becoming more and more popular. Learn what exactly an EDC is and how to collect & manage clinical data for MedTech in this blog post.
Our free training webinars help medical device professionals keep up with industry best practices, navigate regulatory changes, and achieve True Quality.
FDA regulatory expert Eric Henry provides an overview of the QMSR proposed rule, explains next steps in the rule-making and implementation process, and covers important considerations for medical device manufacturers.
This webinar provides valuable insights and actionable tips on how to demonstrate compliance to the EU’s Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements (GSPR).
Gain insights into alternatives to PMCF clinical investigations and learn ways to accommodate clinical data for compliance with the PMCF requirements under the EU MDR.
A "how to" for DHF/TF and RMF creation for both SaMD and hardware devices, expanding on the key differences between hardware and software Technical File and Risk Documentation, with best practices for achieving compliance for each.
Learn techniques and tips to prepare your technical documentation per Annex II and Annex III and how to respond to your Notified Body, as well as get updates on the latest EU news and other relevant regulatory authorities.
This webinar offers valuable insights on how medical device companies can optimize their clinical strategy for entering multiple markets.
Gain the knowledge, skills, and strategies necessary to successfully implement IEC 62304, ensuring regulatory compliance while developing superior medical device software.
Research findings from recent MDCG guidance, industry and Notified Body surveys, and personal stakeholder interviews on first hand experiences with implementation with a goal to bring advice on the process to the forefront.
Learn what the main requirements are for Good Clinical Practice (GCP), strategies for successfully fulfilling these requirements, and why it is so important for medical device studies.
Learn best practices for effective complaint handling to avoid timely and costly mistakes as well as creative ways to use complaint handling to your advantage.
The Global Medical Device Podcast is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
In this episode we speak with Mike Drues about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what FDA's guidance means and doesn't mean.
In this episode we talk to Mike Drues about how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate.
In this episode we talk with Steve Gompertz about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS.
In this episode we talk to Tom Rish about the differences between user needs and design inputs and the pitfalls companies get into when building design controls.
In this episode we discuss the new cybersecurity guidelines from FDA, what the agency can and can’t say about it, and what kinds of deficiencies medical device manufacturers can expect in the future because of the new legislation.
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Tory Lopez is a Senior Manager of Content Marketing at Greenlight Guru, the #1 provider of purpose-built MedTech solutions, with 5+ years of experience in the medical device industry and 10+ years in sales and marketing. Tory leads a dynamic team of writing and creative professionals, overseeing content strategy,...