All "Fda" articles

QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained

The United State Federal Drug Administration (FDA) recently presented its Quality Management System Regulation or QMSR, harmonizing FDA 21 CFR 820 ...

5 things we learned at the PDA/FDA Joint Regulatory Conference 2023

PMA submissions: 4 PMA application methods for medical devices

Guide to 21 CFR Part 11 compliance [free checklist]

PMA meaning: understanding FDA pre-market approval

21 CFR Part 820: the complete overview

The 3 FDA medical device classes: differences and examples explained

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 ...

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 ...

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 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 ...

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 ...