“Dot Compliance has helped us be more efficient in our processes, while also maintaining a high level of compliance in a highly regulated industry.”
Medical Device Quality Management Solution
Get life-saving medical devices to market faster with an eQMS
Join the Industry’s Leading Life Sciences Professionals Who Trust Dot Compliance
Leading Quality and Compliance Solutions for the Medical Device Industry
Proactive Quality Management
A proactive quality approach is essential in the medical device industry, where patient safety relies on early detection and prevention. Dot Compliance enables teams to identify, track, and resolve issues before they escalate into noncompliance or recalls. The system automates CAPA management and connects it to deviations, complaints, and audits for complete traceability. AI-driven insights reveal trends and risks, helping teams act early and strengthen process control. With automated workflows and real-time visibility, organizations maintain compliance, minimize risk, and drive continuous improvement.
Greater Supply Chain Visibility
Medical device manufacturing relies on complex supply chains where quality risks can occur at any stage. Dot Compliance centralizes supplier quality management to ensure all partners meet regulatory and internal standards. The system manages qualification, audits, performance tracking, and corrective actions in one place, linking each supplier to related records for full traceability. This visibility helps teams detect issues early, improve collaboration, and resolve nonconformances quickly—protecting product quality, maintaining compliance, and preventing costly delays.
Unified Processes
Standardization is key to maintaining compliance and efficiency across departments. Dot Compliance unifies quality, regulatory, and operational processes in one validated system, ensuring consistency and collaboration between teams. Automated workflows enforce SOPs and approval paths, supporting ISO 13485 and FDA 21 CFR Part 820 requirements. Linked records for changes, deviations, and training create full traceability, reducing silos and duplication. With connected data and real-time access, medical device companies can make faster, informed decisions and maintain continuous compliance.
How Dot Compliance Helps
Proactive Quality Management
Don’t react to adverse events, prevent them from occurring in the first place. Dot Compliance’s eQMS helps medical device organizations take a proactive approach to quality, so you can tackle quality events before they threaten patient safety.
Quality and Compliance Enforcement Across the Entire Supply Chain
With Dot Compliance eQMS solutions, you can manage and automate your entire quality ecosystem within a single source of truth. Promote collaboration and ensure your organization and outsourced suppliers get the required visibility in real-time from early product development – design history files (DHF) and device master records (DMR), manufacturing – to post-market surveillance.
Connected Quality and Regulatory Enforcement
Dot Compliance’s cloud-based, end-to-end quality management solutions mitigate risks and ensure visibility and traceability. They integrate data from the beginning of the design cycle to manufacturing, all the way to post-market surveillance—all while ensuring compliance with regulations such as 21 CFR Part 11, 21 CFR Part 820, GMP, ISO 13485, ISO 9001, and others.
The ready-to-deploy 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.
FAQs
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.
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?
Absolutely. Our modular platform lets you start with what you need today and add more over time as your organization grows.
How does Dot Compliance support life sciences companies?
Dot Compliance provides a comprehensive eQMS tailored to life sciences. It covers everything from document control and CAPA management to training and regulatory compliance and much more.
How does Dot Compliance ensure fast implementation?
Dot Compliance offers pre-configured, ready-to-deploy solutions that allow for rapid deployment, enabling life sciences companies to get up and running quickly without extensive customization.
Can Dot Compliance integrate with existing systems?
Yes, Dot Compliance integrates easily with ERP systems and other critical tools through its native Salesforce platform, providing seamless connectivity.
Global compliance, baked in
Quality & Compliance Standards
- ISO/IEC 42001 (AI Management Systems)
- ISO 9001 (Quality Management Systems)
- ISO/IEC 27001 (Information Security Management Systems)
- GAMP 5 (Good Automated Manufacturing Practice for GxP Systems)
- ISO/IEC 27017 (Cloud Security)
Medical Device
- 21 CFR Part 820
- ISO 13485
- ISO 14971
Pharma & Biotech
- 21 CFR Part 210
- 21 CFR Part 211
- cGMP, cGDP, GCP