FDA
The 3 FDA medical device classes: differences and examples explained
Learn about the 3 FDA medical device classes. We give comprehensive definitions, examples, and differences of Class I, II, and III devices.
5 things we learned at the PDA/FDA Joint Regulatory Conference 2024
We headed to Washington to get the latest pharma and biotech quality news straight from the PDA/FDA joint regulatory conference! Here's what we learned.
PMA submissions: 4 PMA application methods for medical devices
Learn the key steps of the FDA's Pre-Market Approval (PMA) submission process and the different types of PMA applications for your medical device.
![Guide to 21 CFR Part 11 compliance [free checklist]](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2Fpy379f3b%2Fproduction%2F0c1a8f07b03440be0f4e3ef554322f61b39f79a1-450x300.png%3Frect%3D0%2C10%2C450%2C281%26w%3D600%26h%3D375&w=3840&q=75)
Guide to 21 CFR Part 11 compliance [free checklist]
FDA 21 CFR Part 11 compliance is a crucial requirement for regulated companies. Learn how to comply by giving yourself airtight control of your electronic records and signatures.
PMA meaning: understanding FDA pre-market approval
Learn what you need to know about the rigorous FDA PMA process including preparing data, documentation and more.
21 CFR Part 820: the complete overview
Find out everything you need to know to comply with FDA 21 CFR Part 820, the FDA's quality system requirements for medical devices.
5 ways to make the FDA audit process easier for your life sciences company
FDA audits are a part of running a life sciences company. These 5 FDA audit preparation tips will improve your readiness and make things easier for your team.
What is the FDA 21 CFR? Requirements Overview
Need information on FDA 21 CFR? Simply put, the Code of Federal Regulations, Title 21 is...
FDA to Issue New Guidance on QMS Validation: 4 Major Changes
The FDA plans to issue new guidance on QMS validation. Here are some of the changes that we...
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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 2002.