Streamline quality with the AI-powered ISO 13485 QMS
Ensure compliance with the leading QMS software.
Most cost-effective & agile
Scalable with out-of-the-box solutions
Adaptable compliance workflows
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Why leading medical device companies choose our QMS solution
Get record time to value
Our ready-to-deploy eQMS comes pre-built and pre-validated, incorporating industry best practices and key workflows out of the box. This means faster implementation, lower total cost of ownership, and reduced IT risk.
Dot Compliance’s Dottie is your personal AI quality guide: the industry’s first AI assistant specifically trained on quality and compliance workflows. Hundreds of life sciences organizations trust Dottie to help them strengthen quality processes, save time, and reduce organizational costs and risk.
Dot Compliance eQMS solutions are built on the Salesforce platform and deliver 100% native Salesforce compliance – providing unmatched flexibility, consistent user experience, operational efficiency, data integrity and security, and scalability.
“Dot Compliance has resulted in improved efficiency, giving us greater control, and has enabled us to make data-driven decisions.”
Carolyn Keeley QA Specialist
The ISO 13485 QMS software that delivers speed and smarts
Our solutions are trusted by life sciences companies worldwide and thousands of users. We are fully compliant with21 CFR Part 11, EU Annex 11 and support ISO 9001, 13485, 14971 and 27001.
Document management
Change Management
Quality Event Management
Audit Management
Training Management
CAPA Management
Deviations
Complaint Management
Risk Management
Supplier Quality Management
Get a Demo of the AI-Powered ISO 13485 QMS Software
Discover how our QMS helps hundreds of top medical device companies stay compliant.
