Medical Device Quality, Regulatory and Product Development Blog

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

By Nick Tippmann on August 9, 2019

In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative,...

When Should You Start a QMS?

By Nick Tippmann on August 7, 2019

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

By Agile Medical Device Design (AMDD) on August 4, 2019

Table of Contents Overview - Agile Design and Development for Medi...

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

By Nick Tippmann on July 31, 2019

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)

By Jon Speer on July 28, 2019

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

By Nick Tippmann on July 26, 2019

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

By Nick Tippmann on July 24, 2019

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including ...

6 Most Common Mistakes When Implementing ISO 13485

By Jon Speer on July 21, 2019

Companies must establish and maintain a quality management system in order to ensure they are produc...

Importance of Software Requirements in Product Development

By Nick Tippmann on July 17, 2019

Software and other requirements are critically important to medical device product development.

Everything You Need To Know To Perform Effective Root Cause Analysis

By Jon Speer on July 14, 2019

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

By Nick Tippmann on July 12, 2019

If you or your child have ever experienced ear infections, you know how difficult (and painful) they...

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