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All "Fda" articles

Medical Devices
• March 13, 2025

What is the FDA QMSR?

The ISO 13485 vs 21 CFR 820 binary has posed a key quality challenge for American medical device manufacturers for a long time. But now that ...
FDA
• January 14, 2025

The 3 FDA medical device classes: differences and examples explained
FDA
• September 17, 2024

5 things we learned at the PDA/FDA Joint Regulatory Conference 2024
FDA
• August 09, 2023

PMA submissions: 4 PMA application methods for medical devices
FDA
• July 20, 2023

Guide to 21 CFR Part 11 compliance [free checklist]
FDA
• July 19, 2023

PMA meaning: understanding FDA pre-market approval
FDA
• July 03, 2023

21 CFR Part 820: the complete overview
FDA
• May 27, 2022

5 ways to make the FDA audit process easier for your life sciences company

Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the ...
Medical Devices
• July 27, 2021

How Long Does the FDA Medical Device Approval Process Take? [Timeline]

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...
FDA
• May 06, 2021

What is the FDA 21 CFR? Requirements Overview

What is the best way to ensure that your medical device complies with all applicable laws and regulations? Title 21 of the Code of Federal ...
FDA
• October 15, 2020

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

Are you having difficulty validating a quality management system (QMS)? As you know, validation provides a level of confidence in the software's ...
FDA
• September 01, 2020

What Are The Top FDA Software Validation Requirements? [Review]

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in ...