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Bridging the Gap between Medical Devices and Clinical Data - Featured Image

Bridging the Gap between Medical Devices and Clinical Data

Selling a medical device in the EU? Understanding the importance of clinical data and what's require...
How to Make the Most of True Quality 2022 - Featured Image

How to Make the Most of True Quality 2022

True Quality 2022 is a one-of-a-kind MedTech conference focused around the theme of quality and desi...
Explaining UDI Requirements for GUDID and EUDAMED - Featured Image

Explaining UDI Requirements for GUDID and EUDAMED

Recent numbers from the World Health Organization indicate there are at least 2 million different ty...
Ultimate Guide to Clinical Evaluation of a Medical Device in the EU - Featured Image

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

Navigating the Medical Device Single Audit Program (MDSAP) - Featured Image

Navigating the Medical Device Single Audit Program (MDSAP)

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory require...
30/60/90 Day Plan to Making an Impact as a Product Development Engineer - Featured Image

30/60/90 Day Plan to Making an Impact as a Product Development Engineer

To say product development engineers are important to medical device development would be the unders...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
Bringing Augmented Reality MedTech to Market - Featured Image

Bringing Augmented Reality MedTech to Market

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablat...
How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4) - Featured Image

How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4)

If you plan on selling a medical device in the European Union, then you should plan on writing a cli...
Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4) - Featured Image

Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4)

All of your hard work has been leading up to this. So far in the clinical evaluation process, you’ve...
Making Your Informational Meetings with FDA Valuable & Worthwhile - Featured Image

Making Your Informational Meetings with FDA Valuable & Worthwhile

What are informational meetings with the FDA, why should you schedule them, and how should they be c...
Everything You Need to Know About Root Cause Analysis - Featured Image

Everything You Need to Know About Root Cause Analysis

At some point, every medical device company will encounter an issue that requires an internal invest...

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