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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...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm - Featured Image

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Do you love quality and regulatory and keeping up with all things related to the medical device indu...
ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016 - Featured Image

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

One thing that seems to be constant in the global medical device industry is change.

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