AI-Powered Operations for Medical Device Companies
Streamline regulatory processes, accelerate R&D, and enhance quality management with an AI platform trained on the complexities of the medtech industry.
50%
Faster Regulatory Submissions
Accelerate 510(k) and PMA documentation
30%
Reduced R&D Cycles
AI-driven analysis of trial and performance data
40%
Lower Compliance Risk
Proactive monitoring of regulatory changes
25%
Improved Complaint Resolution
Faster root cause analysis from QMS data
Knowledge Domains
Regulatory & Compliance
- FDA 21 CFR Part 820
- EU MDR & IVDR
- ISO 13485 Quality Systems
- Global Submission Dossiers
Research & Development
- Clinical Trial Data Analysis
- Predictive Maintenance Modeling
- Biocompatibility Assessments
- Device Verification & Validation
Quality Management (QMS)
- CAPA Process Automation
- Post-Market Surveillance
- Complaint Handling & Reporting
- Supplier Quality Audits
Real-World Examples
What are the documentation requirements for a Class II device submission under the EU MDR?
The EU MDR requires a full technical documentation file, clinical evaluation report (CER), and a declaration of conformity. Key sections include device description, risk management file, and post-market surveillance plan. [Source: Regulation (EU) 2017/745]
Analyze our pre-clinical data to predict the failure rate of this new catheter material over a 5-year period.
Based on the accelerated aging data, the predictive model indicates a 98.5% reliability rate over 5 years, with the primary failure mode being material fatigue at flexion points. [Source: Internal Pre-Clinical Study XYZ.123]
Identify trends in post-market complaints for our infusion pump Model 3.
Analysis of the past 12 months of complaint data shows a recurring issue with alarm malfunctions, accounting for 62% of all reports, primarily from software version 2.1. [Source: Internal QMS Database]
Key Benefits
Accelerate Time-to-Market
Streamline the creation and review of complex regulatory submissions and design documentation to get products to market faster.
Enhance Global Compliance
Stay ahead of evolving regulations like EU MDR and FDA guidance with an AI that constantly tracks and synthesizes compliance requirements.
Improve Product Quality & Safety
Leverage AI to analyze QMS data, identify root causes of failures, and proactively address quality issues before they escalate.
Boost R&D Efficiency
Empower engineers with instant access to analyzed clinical data, research papers, and design history files to make faster, data-driven development decisions.