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Streamline quality with the AI-powered medical device 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 Software

AI-powered. Ready-to-deploy.

AI-powered. Ready-to-deploy.

Move faster with the industry's first pre-validated, ready-to-deploy QMS, purpose-built for life sciences. Accelerate your deployment, leverage built-in best practices, and harness AI-powered quality management from day one.
Native to Salesforce

Native to Salesforce

Dot Compliance is 100% Salesforce-native, which means you get a consistent user experience,  easy integration with existing systems, and scalability and security right out of the box. 
Trusted by life sciences

Trusted by life sciences

Purpose-built for pharma, biotech, and medical device companies, Dot Compliance streamlines quality processes, simplifies regulatory compliance, and accelerates time to market.

Chosen by teams like yours

From fast-growing startups to global leaders, life sciences companies choose Dot Compliance to modernize their quality systems.

Our story
“Dot Compliance has resulted in improved efficiency, giving us greater control, and has enabled us to make data-driven decisions.”
Carolyn Keeley,
QA Specialist at VLE

FAQs

Is Dot Compliance validated?
Yes. All of our solutions come with full validation packages and meet global regulatory standards, including 21 CFR Part 11 and EU Annex 11.
Can I start small and scale later?
Absolutely. Our modular platform lets you start with what you need today and add more over time as your organization grows.
What support is available after go-live?
Our customer success and support teams are with you every step of the way. You'll also have access to knowledge resources, product updates, and more.
Do I need Salesforce to use Dot Compliance?
No. Dot Compliance runs on the Salesforce platform, but you don't need a separate Salesforce license. Everything you need is included.

Global compliance, baked in

Medical Device

Built to help manufacturers meet global device regulations and quality system standards, including:
  • 21 CFR Part 820
  • ISO 13485
  • ISO 14971

Pharma & Biotech

Designed to help pharmaceutical and biotech organizations meet global manufacturing and compliance standards, including:
  • 21 CFR Part 210
  • 21 CFR Part 211
  • cGMP, cGDP, GCP

Quality & Compliance Standards

Dot Compliance is certified to:
  • ISO/IEC 42001 (AI Management Systems)
  • ISO 9001 (Quality Management Systems)
  • ISO/IEC 27001 (Information Security Management Systems)
  • ISO/IEC 27017 (Cloud Security)
Quality & Compliance Standards

The ready-to-use QMS software that delivers speed and smarts

Used by life sciences organizations around the world, Dot Compliance empowers teams to manage quality with confidence, maintain continuous compliance, and keep every process inspection ready.
  • Document Management
    Document Management
  • Audit Management
    Audit Management
  • Complaint Management
    Complaint Management
  • Equipment Management
    Equipment Management
  • Change Management
    Change Management
  • Training Management
    Training Management
  • Risk Management
    Risk Management
  • Electronic Batch Management
    Electronic Batch Management
  • Quality Event Managementl
    Quality Event Management
  • CAPA Management
    CAPA Management
  • Supplier Quality Management
    Supplier Quality Management

Get a Demo of the AI-Powered QMS Software

See why leading pharma, biotech, and medical device companies rely on our AI-powered QMS to stay compliant.