MAE Group Blogs
Immerse yourself in the wealth of knowledge within MAE Group’s Blog Library. Uncover profound insights, expert perspectives, and cutting-edge advancements in medical innovation.
Being Different Makes a Difference
Being different makes a difference. That’s why I began MAE Group, to use my own…
From Assessment to Approval: MAE Group’s Journey to CE Marking for Molecular Breast Imaging Devices
Goal The project goal was to secure CE Marking for a Molecular Breast, Imaging medical…
Denovo: A Path for Novel Devices
There are many reasons the FDA’s De Novo applications grow monthly. Simply put, the more…
Small & Medium Enterprise Solutions
Whether you’re a small or medium size enterprise, MAE Group Solutions has you covered. MAE…
Early Stage Solutions
MAE Group is the capstone between the inventor and investor. We offer a full bespoke…
Getting FDA Approval: Step-by-Step
Congratulations on creating a marketable and perhaps life saving device. Now, it’s time to get…
Honoring Dr. Dario Rodrigues
“Cancer is relentless, so we must be relentless too.” Relentless: oppressively constant; incessant. Cancer never…
Quality Management Demystified
Drugs and Biologics in Cosmetics – Who’s Paying Attention?
According to the Food and Drug Administration’s (FDA) website, “FDA’s legal authority over cosmetics is…
What is a Design History File?
Why Do You Need a Design History File? In short, the FDA requires a Design…