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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
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
Establishing a QMS

How MHRA is Regulating Medical Devices in the UK after Brexit

February 22, 2024
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in the regulatory landscape resulting from Brexit are relevant to you. Read More
Regulatory Submission

Navigating Clinical Evaluations and Investigations in MedTech

January 12, 2024
In an era where technological advancements and regulatory requirements are constantly evolving, the MedTech industry faces the critical challenge of enhancing both safety and... Read More
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

January 3, 2024
Getting a medical device to market is a huge accomplishment for any MedTech company. Design and development, regulatory approval, supplier management and manufacturing,... Read More
Product Development

Most Popular Medical Device Content in 2023

December 15, 2023
2023 was a busy and exciting year here at Greenlight Guru. Over the past 12 months, we’ve been listening closely to our customers, innovating our products, and winning... Read More
Post-Market Surveillance

Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System

December 6, 2023
Whether you’ve got a new clinical trial on the horizon, or you’re just fed up with the limitations of the way you’re currently capturing clinical data, you’ve probably got a... Read More
Regulatory Submission

Recent FDA Draft Guidances

November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
Regulatory Submission

Planning an FDA Submission

November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More

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