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About PriMed

PriMed Instruments Inc. is an FDA registered medical device manufacturer.

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:

ISO13485:2003
21 CFR 820
MDD 93/42/EEC
CMDCAS

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: info@primedinstruments.com

We are ready to discuss and serve your Quality needs.
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