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Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near - Featured Image

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficu...
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes? - Featured Image

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...
12 Medical Device Experts Offer Best Tips for How to Succeed in 2021 - Featured Image

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

How will COVID-19, new regulatory programs and changes, and technological advancements impact your m...
Positive and Negative Impacts of EUA on the Medical Device Industry - Featured Image

Positive and Negative Impacts of EUA on the Medical Device Industry

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly uti...
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
How to Write a Nonconformance Report - Featured Image

How to Write a Nonconformance Report

Nonconformance is a word no quality manager wants to hear.
What is a Multiple Function Device? - Featured Image

What is a Multiple Function Device?

What is a multiple function device? From a high level, it’s a product with at least one portion that...
Challenges related to Home Use Devices - Featured Image

Challenges related to Home Use Devices

What could go wrong as more medical device products are used at home and in similar non-traditional ...
Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...
How Jon Speer Met His Most Frequent Guest: Mike Drues - Featured Image

How Jon Speer Met His Most Frequent Guest: Mike Drues

Reminiscing about past and present lessons learned from listening to conversations with this show’s ...
What are the Audit Etiquette Rules I Should be Following? - Featured Image

What are the Audit Etiquette Rules I Should be Following?

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself acco...
5 Tips for Medical Device Registration across Global Markets - Featured Image

5 Tips for Medical Device Registration across Global Markets

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...

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