ISO 13485

Medical Device Quality Management System compliance for HealthTalk.

Overview

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Scope

HealthTalk is classified as a medical device software component used in healthcare communication workflows. The QMS covers:

Design and development of HealthTalk software
Production and service provision
Customer communication management
Regulatory compliance monitoring

Key Requirements

4. Quality Management System

QMS documentation maintained
Quality manual and procedures defined
Records management processes established

5. Management Responsibility

Quality policy defined and communicated
Management reviews conducted regularly
Resources allocated for QMS maintenance

6. Resource Management

Personnel competency requirements defined
Training records maintained
Infrastructure requirements documented

7. Product Realization

Design and development procedures
Risk management per ISO 14971
Design verification and validation
Change control procedures

8. Measurement, Analysis and Improvement

Customer feedback collection
Internal audit program
CAPA (Corrective and Preventive Action)
Statistical techniques for monitoring

Documentation

Quality Manual (QM-001)
Design Control Procedure (SOP-001)
Risk Management Procedure (SOP-002)
CAPA Procedure (SOP-003)
Document Control Procedure (SOP-004)

Certification

Current certification details available upon request from compliance@medrecord.nl.