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

Bridging the Gap between Medical Devices and Clinical Data

By Nick Tippmann on April 20, 2022
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

By Kennedy Gennari on April 18, 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

By Etienne Nichols on April 17, 2022
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

By Niki Price on April 15, 2022
Navigating the Medical Device Single Audit Program (MDSAP) - Featured Image

Navigating the Medical Device Single Audit Program (MDSAP)

By Nick Tippmann on April 13, 2022
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

By Etienne Nichols on April 8, 2022
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

By Etienne Nichols on April 8, 2022
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

By Nick Tippmann on April 6, 2022
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)

By Niki Price on April 3, 2022
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)

By Niki Price on April 1, 2022
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

By Nick Tippmann on March 30, 2022
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

By Brittney McIver on March 27, 2022
At some point, every medical device company will encounter an issue that requires an internal invest...

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