IBM Engineering Requirements Management DOORS Next vs. Aligned Element

IBM Engineering Requirements Management DOORS Next is a scalable management solution for the communication, collaboration and verification of your requirements. It enables you to capture, trace, analyze and manage changes to requirements while maintaining compliance to your industry’s specific regulations and standards. With DOORS Next, you can improve time to market, product quality and lower costs through the comprehensive management of requirements from beginning to end of your development project.

The Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.