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Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. ...
Career Tips for QA/RA Professionals in the Medical Device Industry - Featured Image

Career Tips for QA/RA Professionals in the Medical Device Industry

Medical device quality and regulatory professionals face changes, challenges, requirements, standard...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...
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...
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 ...
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.
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...
5 Most Common Mistakes Made When Implementing ISO 14971 - Featured Image

5 Most Common Mistakes Made When Implementing ISO 14971

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...

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