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eBooks and Guides

State of Medical Device Quality Management and Product Development Report

Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research findings from hundreds of medical device professionals.

Ultimate Guide to Training Management for Medical Device Companies

Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the members of a medical device organization.

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

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.

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Webinars

Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

A free, in-depth webinar covering BDD and STeP application processes and why getting these designations early in the regulatory process can help clear a device’s pathway to approval.

5 Key Points to Consider in Design Transfer of Medtech

Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at Cirtronics, who share tips from their decades of experience transferring new product designs for medical products into manufacturing.

10 QMS Musts for SaMD and Devices Featuring Software (and how to best utilize for product & team success)

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.

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Global Medical Device Podcast

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Episode 229

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Episode 228

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Episode 227

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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 IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."

How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."

How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."

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In The News
EU MDR Preparedness: How Is COVID-19 a Factor?

EU MDR Preparedness: How Is COVID-19 a Factor?

By Jon Speer
Medical Product Outsourcing July 6th, 2021

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

By Brandon Henning
Medical Product Outsourcing July 1st, 2021

Closed-Loop Traceability for FDA Compliance

Closed-Loop Traceability for FDA Compliance

By Jon Speer

Quality Digest, June 2, 2021

View All Articles