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ISO 13485

ISO 13485 Requirements

Any medical device or IVD placed on the European market must comply with the relevant classification MDR and IVDR requirements or in the US compliance and approval to FDA regulations for Medical devices:21CFR.

Product and user safety are critical for medical device compliance. ISO 13485 specifies requirements for a quality management system which can demonstrate a company’s ability to design and manufacture medical devices & IVDs that consistently meet applicable regulatory requirements and customer specifications.

The significant benefits of ISO 13485 for our clients are:

  • It ensures consistency in what we do
  • It identifies ways to constantly measure and improve
  • It enables a risk-based approach
  • It supports our customers confidence and satisfaction
  • It demonstrates evidence of compliance with applicable regulations for safety and performance

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