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January 5, 2023

Should My Class I Device Have Design Controls?

Design controls are a set of processes and procedures that are used to ensure the safety and effectiveness…

December 22, 2022

When Do You Need an IRB?

IRB or Institutional Review Board is an FDA-approved group that’s responsible for monitoring any biomedical research or study…

December 14, 2022

Outlining the Design Control Process of Medical Devices

In the medical industry, Design Controls facilitate the structural and developmental process of medical devices, particularly Class II…

December 8, 2022

Risk Management: A Brief Overview

Risk management is identifying and controlling legal, financial, health, and strategic risks to an organization’s capital. To appropriately…

December 1, 2022

Big Savings For Small Businesses – Does Your Medical Device Company Qualify?

While very rewarding, it is no surprise that being an entrepreneur in the medical device industry will come…

November 23, 2022

Handling Rejection – What to Do If the FDA Doesn’t Accept Your 510k Application

My 510(k) application was rejected by the FDA, but I don’t understand why? So, your 510(k) was not…

November 16, 2022

Why Is ISO 13485 Training Critical to Building a Career in Medical Devices?

The medical device industry is booming. The U.S. medical device manufacturing market was valued at 176.7 billion USD…

November 9, 2022

Annex 11 & Part 11: What’s the Difference?

What’s Part 11? In the early 1990s, computerized systems were becoming increasingly normal in business, and Industry professionals…