Quality / Certifications

At Medbio, we assume the responsibility of providing our customers the highest quality products, on time.

ISO 13485:2016 certified and FDA registered, Medbio works to exceed 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 Assurance Team

Quality Policy

At Medbio, we are committed to delivering high-quality products and exceeding customer expectations.

We achieve this based on the Medbio values:

Continuous Improvement

Accountability

Respect

Excellence

Service

While maintaining effective processes, product conformity, and the Quality Management System.

Quality Assurance

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, cleanroom certification, and other custom QA procedures.
  • Full annual internal audit schedule

ISO 13485 & 9001
Certifications