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Regulatory Submission

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

April 2, 2024
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market. Read More
MedTech Lifecycle Excellence

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

March 27, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, respondents cited a number of common challenges related to training management, including: Read More
MedTech Lifecycle Excellence

FDA's Voluntary Improvement Program

March 21, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss... Read More
Product Development

Quality Management Plan - How to Create Yours (Tips & Best Practices)

March 7, 2024
Technically speaking, you can launch a product without a quality management plan—but most of your go-to-market efforts will feel as though you’re shooting from the hip and... Read More
MedTech Lifecycle Excellence

The State of UDI Across the World

March 7, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and... Read More
MedTech Lifecycle Excellence

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

March 5, 2024
In MedTech, an increasing number of companies are introducing devices integrated with AI technologies. Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

March 1, 2024
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
MedTech Lifecycle Excellence

Quality Myths & Lessons Learned Part II

February 22, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. Read More

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