Quality Control and Assurance

  • ISO 13485 with CMDCAS
  • FDA cGMP Drugs and Medical Devices

At Swiss-American, quality means more than standards and certifications; it’s our promise to our customers. Our exemplary quality performance record demonstrates Swiss-American’s commitment to excellence.  Overseeing every step of a project are dedicated teams of regulatory affairs managers, quality engineers and quality inspectors. Their involvement in all areas of our operation ensures adherence to quality standards, compliance with industry regulations, and successful commercializations.

ISO 13485, FDA cGMP validation and even FMA -Japan are among the credentials held by Swiss-American.

ISO 13485 Certificate

State of Texas License for Drug Manufacturing

State of Texas License for Device Manufacturing

FDA registration for Drug Manufacturing

FDA registration for Device Manufacturing

Past 5+ Years of Inspections and Certification Results