Medical Device IT Vendor Review Questionnaire
1. Vendor Information
Vendor Name
Contact Person
Email
Phone
Address
2. Product / Service Information
Product / Service Name
Description
Intended Use
Supported Standards (e.g. DICOM, HL7, FHIR)
3. Regulatory & Compliance
Regulatory Approvals / Certifications
GDPR / HIPAA Compliance
Yes
No
Quality Management System in Use
4. Cybersecurity
User Authentication Methods
Data Encryption Methods
Vulnerability Assessment Practices
Incident Response Process
5. Service & Support
Support Channels
Service Level Agreement (SLA)
Maintenance & Update Policy
6. Additional Notes