Skip to main content
About Us

ISO 13485

eg technology are ISO 13485 accredited.

We put rigorous quality management at the centre of everything we do, providing our clients with compliance to standards for safety, quality, risk management and traceability.

The significant benefits of ISO 13485 certification 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

ISO 13485 Requirements

Any medical device or IVD placed on the market must comply with the relevant classifications:

  • USA: compliance and approval to FDA regulations for Medical devices:21CFR.
  • Europe: MDR and IVDR requirements

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.

We can help you deliver your product to the required standards within regulatory frameworks

Talk to our team