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3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)? - Featured Image

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

Quality management is an essential part of manufacturing any product, regardless of size, complexity...
When to Throw the Least Burdensome Flag on FDA - Featured Image

When to Throw the Least Burdensome Flag on FDA

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional infor...
What is an ISO Audit? - Featured Image

What is an ISO Audit?

When it comes to medical devices, compliance isn’t based on the honor system.
How Should Artificial Intelligence in Medical Devices be Regulated? - Featured Image

How Should Artificial Intelligence in Medical Devices be Regulated?

Take a close look at any global industry and you’ll find them all locked in the same race toward inn...
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc - Featured Image

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the...
What is the FDA Medical Device Registration Process? - Featured Image

What is the FDA Medical Device Registration Process?

To patients and providers, medical devices are more than a product. They serve as the conduit to bet...
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
How the MDSAP Grading System Works - Featured Image

How the MDSAP Grading System Works

The Medical Device Single Audit Program (MDSAP) allows you to have a single audit of your medical de...
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020 - Featured Image

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

What did FDA report as the most-cited issues during medical device inspections for the fiscal year o...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

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