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Establishing a QMS

February 26, 2023

Ultimate Guide to Postmarket Surveillance of Medical Devices

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

October 4, 2022

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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson

July 17, 2022

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Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

Etienne Nichols

One of the biggest factors that determine a medical device company’s success is how effectively they manage quality processes. Read More

Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols

Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More

Product Development

Electronic Data Capture Systems vs. Paper-based Data Collection

Jon Bergsteinsson

In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More

MedTech Lifecycle Excellence

Most Common Problems Found During FDA Inspections in 2022

Etienne Nichols

Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Michael Drues, PhD joins the podcast to talk about the... Read More

Product Development

Making the BOM & Design Controls Connection

Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More

Establishing a QMS

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

Etienne Nichols

One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More

Product Development

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

Páll Jóhannesson

For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing research data to produce high-quality... Read More

Product Development

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Etienne Nichols

What’s the difference between design verification and validation, and why is it so important? Read More

Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols

The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More

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