🏥 Medical Device Regulatory Compliance Tool

Multi-Standard Compliance Assessment for USA & Canada

📋 Regulatory Standards Selection

Select the regulatory standards your medical device needs to comply with

Choose the countries/regions where you plan to market this device

Quality management and risk management standards

🔬 Device Basic Information

Provide general information about your medical device

Describe the specific medical purpose and intended patient population

IVD devices examine specimens from the human body

Yes
No

Device risk classification determines regulatory requirements

⚙️ Technical Characteristics

Technical features and characteristics of your device

Yes
No

Device intended to be totally or partially introduced into the body for ≥30 days

Yes
No

Does it quantitatively measure physiological parameters?

Yes
No

🏭 Manufacturing & Organizational Capabilities

Information about your organization's processes and capabilities

If no, design controls (ISO 13485 §7.3) may be excluded

Yes
No
Yes
No

e.g., sterilization, testing, manufacturing

Yes
No
Yes
No

Ongoing maintenance, calibration, or repairs

Yes
No

Triggers 21 CFR Part 11 requirements (if USA market selected)

Yes
No

Typically required for higher-risk devices without sufficient clinical data

Yes
No

Required for most devices in USA (21 CFR 830) and many other jurisdictions

Yes
No

✅ Regulatory Compliance Dashboard

📋 Compliance Summary
This dashboard shows all applicable regulatory clauses based on your device profile and selected standards. Use the export functions below to generate detailed reports for your compliance team.