Quality System
Capabilities

ISO 13485:2016 Certified

  • Class I, II, and III Devices

FDA 21 CFR Part 820 Compliant

Electronic Quality Management System

Audit
Management

Design
Control

Nonconforming
Materials

Complaint
Handling

Document
Control

Supplier
Management

CAPA
CAPA

Equipment
Management

Training
Management

Quality Management

  • Standard Operating Procedures

  • Process Reviews

  • Monitoring Oversight

  • Regulatory & Compliance

  • Audits and Inspections

  • Training

  • Quality Metrics