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HELPING YOU Imagine, Introduce, and Advance better Medical Devices.

More than 150,000 rely on us for the latest in quality

eBooks and Guides

Ultimate Guide to QA & RA in Medical Device 3D Printing

A white paper to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing technologies to specific regulatory requirements, for commercializing and marketing end-use 3D printed medical devices.

The Risk Management + Design Controls Connection: What Device Makers Need to Know

A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, and sell the most safe and effective devices.

2021 EU MDR Preparedness Study

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 day action plan to get prepared, regardless of your current state of preparedness. 

 
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Webinars

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 market.

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).

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 executing regulatory strategies.

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Global Medical Device Podcast

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Episode 236

What Are The Top Compliance Issues Plaguing Medical Device Manufacturers?

Episode 235

Setting the Record Straight on Usability & Human Factors

Episode 234

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MedTech True Quality Stories Podcast

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Evan Luxon

Co-founder & CEO, Centese

Elevating True Quality with Software Medical Device for Early Cancer Detection and Treatment

Chad McClennan

President, CEO, Koios Medical,

Graham Anderson

CFO, Koios Medical,

Patricia Setti-Laperch

Director of Regulatory Compliance and Quality, Koios Medical

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Becky Fitzgerald

Principal/Co-founder, Two Harbors Consulting

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Case Studies

How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go through.”

How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

“Having partners with common values is just as important as the product or services themselves.”

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end user be a ‘quality guru’."

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In The News
Three Ways To Know Your Medical Device Start-Up Is Ready For Your Next Round of Funding

Three Ways To Know Your Medical Device Start-Up Is Ready For Your Next Round of Funding

By Nick Tippmann

Medical Product Outsourcing December 3rd, 2021

4 Red Flags Investors Look For When Vetting Your Medical Device Company

4 Red Flags Investors Look For When Vetting Your Medical Device Company

By Nick Tippmann

MedTech Intelligence November 22nd, 2021

Risk Management for Medical Devices

Risk Management for Medical Devices

By Wade Schroeder

Quality Digest September 2nd, 2021

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