Quality

Quality
SanaVita Medical has an uncompromised dedication to quality. We understand the importance of quality to the success of your product and the welfare of your patients. We are an FDA registered contract manufacturer and have a quality management system that is compliant with ISO 13485:2016.

FDA Registered Contract Manufacturer:
  • SanaVita manufacturers medical devices to its customer’s specifications
  • Maintains a quality system that complies with the requirements of 21 CFR Part 820 Quality System Regulation
  • Quality System is assessed by our customers during their supplier qualification process and can also be inspected by the FDA
  • Manufacturing occurs in ISO 7 class cleanrooms
  • Continuously monitors production processes to assure that critical to quality (CTQ) features established by its customer are assured
  • Creates unique device identification labels in accordance with customer specifications and applies them to the device packaging
  • Maintains records to assure compliance to customer and regulatory requirements

ISO 13485:2016 Certification:
  • Attained the ISO 13485:2016 certification under the scope of a contract manufacturer for medical devices
  • Quality Management System is assessed by a Notified Body on an annual basis
  • Quality Management System is assessed by customers during their supplier qualification process