Standards Compliance

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Standards Compliance

We can guide your company to compliance and certification according to the following standards:

  • ISO 9000: 2015 Quality management systems – Requirements for distribution companies.  We can also adapt your QS to the applicable part of  ISO 13485:2016 regarding  medical device trading.
  •  ISO 13485:2016 - Quality System Standard designed specifically for medical devices. This standard is mandatory for most Class IIa, IIb and III medical devices and IVDs in Europe.  We offer specific programs for the transition  from  ISO 13485:2003 to ISO 13485:2016.
  • Canadian Medical Devices Regulation
  • U.S. FDA Quality System Regulations

 

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Standards Compliance