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Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market - Featured Image

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing - Featured Image

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...
Challenges with Pediatric Medical Devices - Featured Image

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices.
13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

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 - Featured Image

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

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? - 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...

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