Our Services

Quality

Quality Management System (Establishment, Maintenance, Remediation)
Training Implementation
Internal / External Audit Support
CAPA Management
Field Actions (Corrections, Removals)
Post-Market Surveillance
Risk Management

Regulatory

Regulatory Strategy
FDA Warning Letter Responses
Global Registration Support
Technical File / Design History File Maintenance and Review
Labeling Review
Device Classification
UDI Maintenance

Clinical

Clinical Evaluation Support (CEP, CER)
Risk Management
Response to Clinical Complaints or Adverse Events
Clinical Input for Product Design and Development

QMS Documents

Visit our Shop to purchase SOPs and Templates for you to customize to your QMS. These procedures are compliant with ISO 13485, MDSAP, and EU MDR.

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