Medical Device Quality, Regulatory and Product Development Blog

How to Structure your Medical Device Technical File

By Jon Speer on April 18, 2021

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

By Nick Tippmann on April 15, 2021

MDQMS leader to support national COVID-19 diagnostics program through purpose-built solutions.

Pivoting Operations to Meet PPE Demand during Pandemic

By Nick Tippmann on April 14, 2021

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...

Pros & Cons of Being a Physician turned MedTech Inventor

By Nick Tippmann on April 13, 2021

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...

What is a Quality Agreement for Medical Devices?

By Taylor Brown on April 11, 2021

There’s a good chance you’re not manufacturing your own medical device—contract medical device manuf...

3 Systems of Risk for Medical Devices from FDA

By Nick Tippmann on April 7, 2021

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...

Quality Management for IVD Devices vs Medical Devices

By Nick Tippmann on April 5, 2021

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD...

Am I Complying with FDA Medical Device Labeling Requirements?

By Jesseca Lyons on April 4, 2021

Medical device labeling requirements are a key part of getting your device to market.

Understanding the Investigational Device Exemption (IDE) Process

By Nick Tippmann on March 31, 2021

Does your medical device qualify for an investigational device exemption (IDE)? What does this proce...

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

By Nick Tippmann on March 29, 2021

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself?...

How to Use the FDA ESG (Electronic Submissions Gateway)

By Tom Rish on March 28, 2021

The most competitive medical device companies embrace technology as a tool to make systems and proce...

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

By Nick Tippmann on March 24, 2021

Why is design, manufacturing, quality, and culture so important in the medical device industry?

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