spk-logo-white-text-short2
0%
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends

Introduction

Does your company properly manage Design Outputs?  The FDA routinely examines this area as part of an audit process.   In this article we review what it means to have your design outputs in order as well as present some recent warning letter examples.

We invite you to download our paper on this topic.

Learn more about IT FDA requirements and compliance training best practices to help your business gain the competitive market advantage.

Latest White Papers

How to Prepare Your Organization for an AI Rollout

How to Prepare Your Organization for an AI Rollout

Managing your organization’s knowledge base may be challenging, especially if information is scattered across multiple systems. Discover how Atlassian’s AI Rovo agents help manage this.What You Will Learn In this eBook you will discover: Why knowledge management...

Related Resources

Strategic Approaches to Hospital Medical Equipment Installation

Strategic Approaches to Hospital Medical Equipment Installation

Successful medical equipment installation in hospitals requires continuous stakeholder engagement, infrastructure readiness, testing and training, and continued maintenance.  When done properly, staff can quickly and easily use the devices, directly elevating patient...

Reducing CAD File Errors and Rework

Reducing CAD File Errors and Rework

File mistakes and unnecessary rework remain all too common in the engineering space. Inefficient CAD file management due to poor collaboration and hardware limitations can result in missing details or time-consuming corrections. This is why reducing CAD errors is so...