Streamline quality with the AI-powered ISO 13485 QMS

Ensure compliance with the #1 QMS software. Get a Demo.

  • Most cost-effective & agile
  • Scalable with out-of-the-box solutions
  • Adaptable compliance workflows
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famar
caris
vitalant
insightec
propharma
biopharma
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Meet the top-rated ISO 13485 QMS software

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Get record time to value 

Our ready-to-deploy QMS 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. 

Unlock limitless possibilities with AI

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.

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Leverage the power of Salesforce

Dot Compliance QMS 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.

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“Dot Compliance has resulted in improved efficiency, giving us greater control, and has enabled us to make data-driven decisions.”

 

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Carolyn Keeley 
QA Specialist

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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 with 21 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 #1 ISO 13485 QMS Software

Discover how our QMS software helps hundreds of top life sciences companies stay compliant.