ISO 13485:2016 Certified - FDA Registered



At Medbio, we assume the responsibility of providing our customers the highest quality products, on time. ISO 13485:2016 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 are committed to providing our customers with products of high quality and value, while complying with applicable regulations. By utilizing robust and efficient systems and processes, we will manufacture safe and effective products, delivered on-time, and at a reasonable cost. We will build strong relationships with our customers, and strive for continual improvement in everything we do.

Quality and Metrology

  • FDA registered
  • ISO 13485:2016 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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