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When Should You Start a QMS? - Featured Image

When Should You Start a QMS?

Early-stage startups often wonder when the right time is to consider a quality management system (QM...
Ultimate Guide to Agile Design and Development for Medical Devices - Featured Image

Ultimate Guide to Agile Design and Development for Medical Devices

                                Table of Contents   Overview - Agile Design and Development for Medi...
How General Wellness Devices Have Opened a Pandora's Box of Confusion - Featured Image

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor ...
What is a Quality Culture? (and 7 tips for creating one) - Featured Image

What is a Quality Culture? (and 7 tips for creating one)

In the medical device industry, the word quality can mean different things to different people. To s...
A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP - Featured Image

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality P...
Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device - Featured Image

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including ...
6 Most Common Mistakes When Implementing ISO 13485 - Featured Image

6 Most Common Mistakes When Implementing ISO 13485

Companies must establish and maintain a quality management system in order to ensure they are produc...
Importance of Software Requirements in Product Development - Featured Image

Importance of Software Requirements in Product Development

Software and other requirements are critically important to medical device product development.
Everything You Need To Know To Perform Effective Root Cause Analysis - Featured Image

Everything You Need To Know To Perform Effective Root Cause Analysis

Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-marke...
Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections - Featured Image

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

If you or your child have ever experienced ear infections, you know how difficult (and painful) they...
4 Facts That May Surprise You About FDA - Featured Image

4 Facts That May Surprise You About FDA

From creating product codes to following regulations, do you ever wonder what goes on inside the U.S...
Should you Swipe Right or Left on your Notified Body? - Featured Image

Should you Swipe Right or Left on your Notified Body?

How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander? ...

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