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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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How to Prepare for and Manage Audits/Inspections across Global Markets

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.

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical device.

How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for regulatory submission and sales, with minimum burden on budgets and schedules.

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Global Medical Device Podcast

How Mindset Training Can Help Your Team Operate at Peak Performance

Episode 212

Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Episode 210

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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
Closed-Loop Traceability for FDA Compliance

Closed-Loop Traceability for FDA Compliance

By Jon Speer

Quality Digest, June 2, 2021

Preparing for the EU’s MDR

Preparing for the EU’s MDR

By Nick Tippmann

Medical Product Outsourcing, April 29th, 2021

What Are the Biggest Changes under EU MDR?

What Are the Biggest Changes under EU MDR?

By Jon Speer

MedTech Intelligence, April 14th, 2021

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