Ensure medical device quality. Accelerate innovation.
Built for speed, safety, and compliance, Intellect's AI-powered QMS helps Medical Device manufacturers streamline processes, reduce risk, and bring high-quality products to market faster.
Smarter quality for safer devices
- Combine industry-leading QMS functionality with AI intelligence to help you maintain global compliance, mitigate risk, and manage change—all in one platform.
- Whether you’re launching a new Class I, II, or III device or responding to a post-market complaint, Intellect gives you complete control over quality events, design history, and documentation.
- Stay connected on any device—desktop, tablet, or mobile—so you can take action in real time, from the clean room to the boardroom.
- Streamlined Regulatory Compliance
Ensure readiness for FDA 21 CFR Part 820, ISO 13485, EU MDR, and other global regulations with AI-assisted traceability, validation, and document control.
- Automated Document Control and Audit Readiness
Maintain always-inspection-ready records with automated document workflows, version control, and e-signatures. Simplify internal and external audits with instant access to approval history, training records, and change logs.
- Closed-Loop Risk and CAPA Management
Link complaints, nonconformances, and CAPAs in one traceable system. Use AI to detect patterns, recommend actions, and reduce time-to-resolution.
- Data Privacy, Guaranteed
Your proprietary product data stays protected. Intellect’s AI runs in a secure, closed-loop environment where data is encrypted and never shared or used externally.
Take the guesswork out of quality and compliance.
Leading medical device teams use Intellect to avoid recalls—and audits.
- Reduce audit prep time by up to 50% with real-time documentation, version control, and AI-powered responses to FDA or notified body inquiries.
- Easily manage DMRs, DHRs, and DHFs in one place—ask Intellect to summarize change history, identify gaps, or auto-generate reports from your data.
Prevent issues before they impact patients
- Use AI to analyze complaints, deviations, and audit findings across product lines and manufacturing sites.
- Surface trending issues early—such as recurring post-market complaints or delayed CAPA closures—and proactively address root causes.
- Get predictive recommendations to reduce risk and improve product lifecycle outcomes.
Adapt and scale with every product launch
Intellect grows with you—from early-stage innovators to global medical device enterprises.
Track and manage:
- Design Control & Change Management
- Document Control & Training
- Risk Management & FMEAs
- eSignatures & Part 11 Compliance
- CAPA, NCR, and Audit Management
Save time. Reduce risk. Speed approvals.
Whether you're responding to an FDA audit or submitting to a notified body, Intellect makes it easy:
- Summarize DHF contents
- Draft a CAPA report
- Compare two versions of a work instruction
- Translate your SOPs into 10+ languages
Let your quality teams focus on product and patient safety—not paperwork.
Intellect’s QMS AI platform empowers your team to innovate with confidence.
Be audit-ready—every day
AI-backed audit tools mean your team can instantly surface documentation, respond to inquiries, and demonstrate compliance—across every stage of your product lifecycle.
From initial design to post-market monitoring, Intellect QMS AI platform keeps you inspection-ready with:
- Automated audit trails
- Up-to-date training records
- Linked CAPA and risk histories
- Real-time validation support
No more scrambling. Just clear, compliant answers—on demand.
Leading medical device teams use Intellect to avoid recalls—and audits.
- Reduce audit prep time by up to 50% with real-time documentation, version control, and AI-powered responses to FDA or notified body inquiries.
- Easily manage DMRs, DHRs, and DHFs in one place—ask Intellect to summarize change history, identify gaps, or auto-generate reports from your data.
Prevent issues before they impact patients
- Use AI to analyze complaints, deviations, and audit findings across product lines and manufacturing sites.
- Surface trending issues early—such as recurring post-market complaints or delayed CAPA closures—and proactively address root causes.
- Get predictive recommendations to reduce risk and improve product lifecycle outcomes.
Adapt and scale with every product launch
Intellect grows with you—from early-stage innovators to global medical device enterprises.
Track and manage:
- Design Control & Change Management
- Document Control & Training
- Risk Management & FMEAs
- eSignatures & Part 11 Compliance
- CAPA, NCR, and Audit Management
Save time. Reduce risk. Speed approvals.
Whether you're responding to an FDA audit or submitting to a notified body, Intellect makes it easy:
- Summarize DHF contents
- Draft a CAPA report
- Compare two versions of a work instruction
- Translate your SOPs into 10+ languages
Let your quality teams focus on product and patient safety—not paperwork.
Intellect’s QMS AI platform empowers your team to innovate with confidence.
Be audit-ready—every day
AI-backed audit tools mean your team can instantly surface documentation, respond to inquiries, and demonstrate compliance—across every stage of your product lifecycle.
From initial design to post-market monitoring, Intellect QMS AI platform keeps you inspection-ready with:
- Automated audit trails
- Up-to-date training records
- Linked CAPA and risk histories
- Real-time validation support
No more scrambling. Just clear, compliant answers—on demand.
Gartner Peer Insights
In their own words
“Intellect QMS was easy to implement and manage, and offers seamless collaboration and centralized product data management. This software is simple, yet effective and easy to start working with. Its pretty affordable, which was also one of the leading factors for implementing.”
This real Intellect user had plenty more to say:
Read the Gartner Peer Insights Review