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.
Mapping the Path to FDA Clearance: MAE Group’s DHF Compliance Efforts in Renal Dialysis
Goal To determine the gaps in documentation between the existing CE Technical File (and other…
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements
Posted By: By Donna Mitchell-Magaldi, Nerac Analyst On March 20, 2010, the revised Guideline; MedDev…
Announcements: Annual Retreat 2022
3 Keys to Understand Regulatory in Med Device
Regulatory device compliance
What is a Design History File?
Why Do You Need a Design History File? In short, the FDA requires a Design…
MAE Group Gets You Out of Overwhelm
First, being a key decision maker and leader in any company becomes a challenge when…
Getting your Product to Market on Time
So you want to release your medical device or pharmaceutical product into the US or…
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…
Honoring Dr. Wenyin Shi
Recently, Dr. Wenyin Shi, an integral member of Project Hope’s Advisory Team, received the 2021…
Small & Medium Enterprise Solutions
Whether you’re a small or medium size enterprise, MAE Group Solutions has you covered. MAE…