We are an ISO 13485:2016 certified provider of contract product development and contract manufacturing. Our Quality Management System offers flexibility while ensuring compliance to provide the highest value to the customer.

We are well suited to create and manage your product Design History File, Risk File, Device Master Record, and production Device History Records.

Our Quality Management System allows us to provide and maintain the best value for our customers:

  • Built from the ground up with the customer’s needs and goals in mind
  • Offers a flexible compliant path through product development and manufacturing
  • 21 CFR 820 compliant
  • ISO 13485:2016 certified
  • ISO 14971:2012 compliant risk management process
  • FDA Establishment Registration Number: 3016020790


“The Program Manager feels like she is part of our team and consistently goes above and beyond to help us meet our quality and schedule requirements. The Meddux team carefully reviews proposed document changes, allowing us to feel comfortable that we are moving forward quickly but also thoroughly.”

Director of Quality
Minimally Invasive Surgery Startup, USA

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