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Product Development

EUA and the Impending Transition

October 26, 2022
There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more... Read More
Regulatory Submission

GUDID 101: Everything You Need to Know About FDA’s Global Unique Device Identification Database

October 23, 2022
After years of planning, implementation, and compliance rollout dates, FDA’s Global Unique Device Identification Database (GUDID) is fully operational. With this in mind, we... Read More
Post-Market Surveillance

Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps

October 23, 2022
Your approved supplier list (ASL) is one of the critical components of medical device supplier management. The ASL is an in-house record of all the suppliers you’ve... Read More
Product Development

3 Common Misconceptions About Medical Device Labeling

October 21, 2022
When you first start designing and developing a new medical device, you’re investing a lot of time, whether that’s in studying design controls, design inputs and outputs, or... Read More
Product Development

Common QMS Mistakes SaMD Companies Make

October 20, 2022
What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Read More
Product Development

10 Best Practices for eCRF in Medical Device Trials

October 20, 2022
Transitioning from paper-based data capture to electronic case report forms (eCRF) improves the quality of data collection, lowers costs, and improves the overall efficiency... Read More
Product Development

How to Integrate UDI into a Quality System for Your Medical Device

October 16, 2022
Unique Device Identification (UDI) is all about ensuring traceability quality in medical devices. However, integrating it into your quality system will require plenty of... Read More
Establishing a QMS

Should ISO 15189 Certification Matter to Medical Device Companies?

October 14, 2022
For medical device manufacturers, a medical laboratory can play a huge role in the success of a product. This is where many types of testing can occur. Whether it’s for... Read More
Regulatory Submission

Basic UDI-DI: What is it and How to Assign it for Your Medical Device

October 14, 2022
Unique device identification (UDI) provides a framework for identifying and tracing medical device distribution all over the world.  Read More

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