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eBooks and Guides

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

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 application of medical device symbols on labels.

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.

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Webinars

How to Proactively Predict & Mitigate Risk throughout the Supply Chain

A free, in-depth webinar presented by Andrew Cole, Director Audit Delivery at Cannon Quality Group, covering proactive strategies for medical device companies to use for predictive risk mitigation throughout the supply chain.

Top Things You Should Know When Developing Software as a Medical Device (SaMD)

A free, in-depth webinar presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to effectively implement and adapt a QMS for SaMD.

Key Pitfalls To Avoid In Medtech Clinical Data Collection

A free, in-depth webinar presented by clinical data experts Páll Jóhannesson and Jón Bergsteinsson from SMART-TRIAL who will help you avoid common pitfalls that make your data collection expensive, time-consuming and complex.
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Global Medical Device Podcast

Demystifying the De Novo Process

Episode 260

Challenges for Regulatory Submission: EU vs. US

Episode 259

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Episode 258
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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
Supplier quality management: What medtech manufacturers need to know

Supplier quality management: What medtech manufacturers need to know

By Nick Tippmann

Med-Tech Innovation, May 17th, 2022

Three Lessons from True Quality 2022

Three Lessons from True Quality 2022

By Nick Tippmann

24x7 Magazine, May 17th, 2022

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols

MedTech Intelligence, March 24th, 2022

View All Articles