- Why Us
Preparing for regulatory submissions isn't an easy feat. In fact, many companies fail the first time. Why? They didn’t get started early enough. Planning ahead, injecting quality into your work, and educating yourself sooner will prepare your teams early so you can go into submissions with confidence. Having a QMS designed specifically for MedTech allows you to navigate the challenges that lay ahead and equips you with the resources you need.
Uncover all the ways that our end-to-end solution built specifically for the MedTech industry can get you on the right track to prepare for regulatory submissions.
"It’s scalable, it’s repeatable, and it’s audit-ready."
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 ...
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-depth guide on medical device classification and requirements under EU MDR.
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 ...
MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being introduced by ...
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 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 ...
By Etienne Nichols MedTech Intelligence March 24th, 2022
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 covering best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming stable.
By Jon Speer Medical Product Outsourcing January 7th, 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, and ...
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 challenges ...
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 market.
A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the ...
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 ...
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, ...
By Jon Speer Medical Product Outsourcing July 6th, 2021
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 ...
By Jon Speer Quality Digest, June 2nd, 2021
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.
By Nick Tippmann Medical Product Outsourcing, April 29th, 2021
By Jon Speer MedTech Intelligence, April 14th, 2021
In this report, we wanted to provide you with a holistic picture of what other medical device teams are doing to prepare for the upcoming EU MDR deadline and give you a full 60 ...
Whether you've fully transitioned, are just getting started, or are planning to enter the EU market in the future, you won't want to miss this free virtual summit that covers ...
By Jon Speer Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020
In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common pitfalls.
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 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 most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.
Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.
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 ...
By Jon Speer Medical Product Outsourcing, January 20th, 2020
By Jon Speer Medical Plastics News, November 11th, 2019
By Jon Speer Medtech Intelligence, November 8th, 2019
By Jon Speer In Compliance, October 31st, 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 ...
By Jon Speer Medical Design & Outsourcing, October 30th, 2019
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 ...
By Jon Speer The MedTech Conference , August 26th, 2019 How prepared is your quality management system for the new requirements of EU MDR for medical devices that will go into ...
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 ...
This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.
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 ...
By Jon Speer Quality Digest, March 19th, 2019
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.
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 ...
ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS platform ...
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 ...
We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the requirements actually mean ...
Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.
Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.
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 ...
By Jon Speer Quality Digest April 30th, 2018
By Jon Speer Med Device Online April 2nd, 2018
By Jon Speer MedCity News March 29th, 2018
By Jon Speer Medical Device and Diagnostics Industry January 31st, 2018
By Jon Speer MedCity News December 21st, 2017
By Jon Speer Medical Device and Diagnostics Industry November 16th, 2017
By Jon Speer MedCity News October 17th, 2017
By Jon Speer Med Device Online October 2nd, 2017
By Jon Speer Med Device Online August 22nd, 2017
By Jesseca Lyons Med Device Online September 19th, 2016
By Jesseca Lyons Medical Product Outsourcing Jesseca Lyons on September 15th, 2016
By Jon Speer Quality Digest August 23rd, 2016
By Jon Speer MedCity News August 18th, 2016
By Jon Speer Medical Device and Diagnostics Industry August 17th, 2016
By Jesseca Lyons Quality Digest August 9th, 2016
By Jon Speer Quality Digest July 5th, 2016
By Jon Speer MedCity News June 6th, 2016
By Jon Speer MedCity News May 19th, 2016
Inspired Imua Podcast April 21st, 2016
By Jon Speer MedCity News March 1st, 2016
By Jon Speer Quality Digest February 8th, 2016
By Jon Speer MedTech Intelligence November 12th, 2015
By Jon Speer MedCity News October 13th, 2015
By Nick Tippmann Mass Device September 25th, 2015
By Jon Speer MedCity News September 23rd, 2015
By Jon Speer OrthoStreams September 3rd, 2015
By Jon Speer Med Device Online July 16th, 2015
By Jon Speer MedCity News June 8th, 2015
Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.