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The quality of the products we develop, design and manufacture is assured by the management commitment to the stringent compliance with one or more of the following Quality Systems:

21 CFR 820

Based on our knowledge and experience we can assist you in a practical way in the following areas:

  • Design of your Quality System
  • Strategies to cost effectively implement your Quality System
  • Regulatory compliance for US, Canada, and Europe
  • Technical File for CE Mark
  • Device Master Records (DMR) for cGMP
  • Writing procedures and instructions
  • Validation Management
  • ISO standards for biocompatibility, packaging, sterilization, shipping/distribution and other related standards
  • Internal audits
  • Preparation for a certification audit

For more information please e-mail us at:

We are ready to discuss and serve your Quality needs