Manufacturing & Quality

Canopy Medical offers Manufacturing & Compliance services to companies involved in medical product development, product launch and production. These services include, but are not limited to:

Quality

  • Risk Management per EN ISO 14971
  • Test & Inspection Equipment Qualifications
  • Supplier Evaluations / Audits
  • Internal Compliance Audits
  • Training
  • Management Representative
  • Quality Management System development compliant to FDA's cGMP, QSR, and EN ISO 13485:
    • Product Development per Design Control regulations
    • Process control
    • Nonconforming Product
    • Management Review
    • Product Realization
    • Storage / Preservation, Handling, Shipping & Receiving
    • Corrective and Preventative Action (CAPA)
    • Internal Audits
    • Supplier/Vendor Controls
    • Equipment Controls
    • Environmental Controls
    • Document Control
    • Training
    • Complaints / Customer Feedback / Post-market Surveillance
    • Inspection, Testing, Acceptance Controls

Manufacturing

  • Process Documentation
  • Process Control Systems
  • Process Validations
  • Material Handling / Inventory Control systems
  • Shipping & Receiving systems
  • Production & Test Equipment Design
  • Production Equipment Qualifications
  • Supply Chain Management
  • Environmental Monitoring
  • Facility Audits