Compliance Overview
HealthTalk is designed to meet the stringent regulatory requirements of the healthcare industry.
Certifications
MEDrecord maintains the following certifications for HealthTalk:
| Standard | Status | Description |
|---|---|---|
| ISO 13485 | Certified | Medical device quality management |
| ISO 62304 | Compliant | Medical device software lifecycle |
| NEN 7510 | Certified | Healthcare information security (Netherlands) |
| GDPR | Compliant | EU data protection regulation |
Compliance Framework
Our compliance program includes:
- Quality Management System (QMS) - Documented processes and procedures
- Risk Management - Systematic identification and mitigation of risks
- Design Controls - Formal design and development processes
- Post-Market Surveillance - Ongoing monitoring and feedback collection
- Audit Trail - Complete traceability of all system activities
Documentation
Compliance documentation available:
- ISO 13485 - Quality management documentation
- ISO 62304 - Software lifecycle documentation
- NEN 7510 - Information security compliance
- GDPR - Data protection documentation
- Audit Trail - Activity logging and traceability
Regulatory Contacts
For compliance inquiries: compliance@medrecord.nl
Audit Support
MEDrecord provides audit support including:
- Access to compliance documentation
- System evidence export
- Traceability matrices
- Technical questionnaire responses
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