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MedTech Lifecycle Excellence

FDA’s PMA Supplements and Amendments: When and How to Use Each

April 19, 2024
The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to... Read More
MedTech Lifecycle Excellence

Speaking the Language of IVD

April 18, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal... Read More
Product Development

Top 50 Medical Device Product Design and Development Companies

April 12, 2024
Medical device companies have to overcome many significant challenges when bringing a new product to market. Along with the exorbitant costs throughout the product design and... Read More
MedTech Lifecycle Excellence

Is It Possible to "Buy" a QMS?

April 12, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. Read More
MedTech Lifecycle Excellence

What is a Class III Medical Device in the US?

April 8, 2024
In the US, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all... Read More
MedTech Lifecycle Excellence

Project Management in MedTech

April 4, 2024
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management... Read More
MedTech Lifecycle Excellence

Greenlight Guru Shines in G2 Spring 2024 Report, Dominating in Medical QMS and EDC Categories

April 4, 2024
This recognition underlines Greenlight Guru's commitment to innovation and customer-centric service in the MedTech industry. Read More
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

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