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Achieving Operational Readiness through Good Project Management - Featured Image

Achieving Operational Readiness through Good Project Management

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Patrick Hayes, Associ...
3 Tips for Planning a Successful Product Development Project for Your Medical Device - Featured Image

3 Tips for Planning a Successful Product Development Project for Your Medical Device

If you’ve ever been involved in the design and development of a medical device, you know just how co...
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...
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 ...
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...
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...
The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4) - Featured Image

The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)

A successful clinical evaluation hinges on your ability to find and appraise the data you’ll need to...

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