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Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More
Product Development

Engineering Change Order: Its Role in the Change Management Process

September 14, 2023
Change is just part of life for medical device companies. No device makes it to market without quite a few changes to its design along the way, and even devices already on... Read More
Product Development

5 Tips for Medical Device Registration across Global Markets

September 14, 2023
You have compiled all of the necessary documentation for your regulatory submission, submitted it to the appropriate regulatory body, and received the much-anticipated news... Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More
Product Development

Creating a Supplier Scorecard for Medical Device Supplier Management

September 6, 2023
A supplier scorecard is one of the most effective tools medical device manufacturers have for assessing the performance of their suppliers. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

September 1, 2023
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Regulatory Submission

MedTech Funding and Preparing for Due Diligence

August 31, 2023
Join guest Devon Campbell as we discuss MedTech funding in this episode of the Global Medical Device Podcast. He unveils startup red flags, from data integrity to product... Read More
Regulatory Submission

Exploring Breakthrough Device Designation

August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. Read More
Product Development

What is the FDA Medical Device Registration Process?

August 22, 2023
To patients and providers, medical devices are more than a product. They serve as the conduit to better quality of life for patients, improve diagnostic speed and accuracy,... Read More

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