Aligned Element vs. qmsWrapper

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.

VALIDATED Medical QMS System purpose built to facilitate compliance with standards ISO 13485, ISO 14971, 21 CFR part 11, ISO 9001 and regulations enacted by the FDA. Very complete including: Document-, Project-, Quality-, Risk-, Training-, CAPA-, Change-,Complaint-, Supplier-, Audit-, Nonconformity Module; Traceability Matrix for DHFs, inbuilt Team Messaging, Processes, Procedure Templates, Quality Manual, Forms, many more, Jira integration. Reliable+Secure+Flexible+Affordable even for startups. Our pricing is for annual subscription.