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Greenlight Guru Medical Device Blog

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Why SaMD Companies Should be Leveraging Pre-Submissions to FDA - Featured Image

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...
What Goes into Designing Devices for Military and Emergency Applications? - Featured Image

What Goes into Designing Devices for Military and Emergency Applications?

There’s one niche market within the device industry that rarely gets the attention it deserves: prod...
Are you Spending Enough Time Defining and Managing Requirements for your Medical Device? - Featured Image

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Some sources claim that one-third of your product development project should be spent on defining go...
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 ...
Meet a Guru: Erica Loring - Featured Image

Meet a Guru: Erica Loring

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decad...
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 ...
Meet a Guru: Wade Schroeder - Featured Image

Meet a Guru: Wade Schroeder

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of m...
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...

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