Regulatory compliance

• 21 CFR part 11

• ISO 13485 (QMSR ISO 13485 aligned)

• Health Canada

• FDA

Product Lifecycle Management

• Risk Management (ISO 14971)

• Design Traceability Matrix (DMR, DHF & DHR)

Quality Management System

• SOP development

• Internal/Supplier audit

• Training

• NC- CAPA

• Complaint Handling

• Continuous Improvement & automation