ISO 13485:2003 Certified - FDA Registered

Quality

Quality

At Medbio, we assume the responsibility of providing our customers the highest quality products, on time. ISO 13485:2003 certified and FDA registered, Medbio satisfies the expectations of the most demanding medical device manufacturers. Whether its problematic transfer tooling or complex new product builds, Medbio will deliver the quality you expect.

Quality Policy

The employees of Medbio, Inc. are committed to providing our customers with products of high quality and value in compliance to requirements of ISO13485. By utilizing robust, error-resistant systems and processes, and taking great care to manage timelines and budgets, we will build strong relationships with our customers while preserving their ability to be profitable and agile in their respective industries.

Quality and Metrology

  • FDA registered
  • ISO 13485:2003 certified
  • Fully capable quality and metrology lab
  • Quality programs can be tailored to suit individual customer’s requirements, such as bioburden measurements, IR scans on incoming resin, clean room certification, and other custom QA procedures.
  • Full annual internal audit schedule
Innovative.  Trustworthy.  Knowledgeable.  Passionate.
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