fbpx
spk-logo-tm-2023
0%
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

FDA Form 483: Top Ten Observations for Medical Devices

windchill features best plm software
Written by SPK Blog Post
Published on July 10, 2013

Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations, they will issue a Form 483 to the firm management at the conclusion of the inspection.

The FDA has issued over a thousand 483 forms yearly for medical devices over the past three years. We review the top 483 citations from FY 2010 – 2012 and show how an efficient product lifecycle management (PLM) environment can help avoid these issues.

Below is a sample. Download our whitepaper for the full view of the top ten observations.

Next Steps:

Latest White Papers

The Ultimate Checklist for Managing CAD Success

The Ultimate Checklist for Managing CAD Success

CAD data management is not always easy. This checklist explores how a structured process can help ensure all data is secure and accessible. Let’s dive more into what drives CAD data management success.What You Will Learn In this eBook you will discover how to: Select...

Related Resources

How Cloud-Based CAD Is Changing the Future of Collaborative Design

How Cloud-Based CAD Is Changing the Future of Collaborative Design

Traditional desktop-based CAD tools, while powerful, can have a hard time meeting the growing demands of modern engineering teams. They need better connectivity, scalability, and flexibility. That’s why cloud-based CAD (Computer-Aided Design) is quickly becoming the...