Regulatory Certifications

OUR QUALITY POLICY

HALIFAX BIOMEDICAL INC. IS COMMITTED TO PROVIDING QUALITY SERVICES AND ADVANCED PRODUCTS WHICH MEET ALL REGULATORY REQUIREMENTS AND ENSURE CUSTOMER SATISFACTION THROUGH CONTINUAL IMPROVEMENTS INĀ ITS QUALITY MANAGEMENT SYSTEM

 

Halifax Biomedical’s quality system, which governs the provision of contract research organization services, as well as the manufacture of the Halifax Imaging Suite, Halifax Imaging Kit, Halifax Bead Inserter, and Halifax Bead Set, is certified to the following standards through SGS United Kingdom Ltd.

ISO 9001:2008
ISO 13485:2003

The system also complies with the following regulatory requirements:

  • Health Canada’s Medical Devices Regulations
  • Canadian Medical Devices Conformity Assessment System (CMDCAS)
  • FDA (Food and Drug Administration) 21CFR820 Quality System Regulations
  • European Medical Device Directive 93/42/EEC (certificate)