Asia has become a major low-cost manufacturing center for device manufacturers located in the United States. DBT provides an array of Medical Device services designed for the Asian Manufacturer - US Device Organization.

Make no mistake - FDA has become critically interested in off-shore manufacturers. We can expect more regulatory actions as FDA ramps up its China-based inspections with Investigators located within-country. The major risk due to serious non-compliance is FDA-administrative actions that bar your product from import into the US.

DBT has hands-on experience in dealing with off-shore contract manufacturers and can help your company in providing services related to:

  • Factory Assessments regarding the state of their quality system
  • Factory Audits for quality system compliance
  • Corrective Actions resulting from assessments and audits
  • Document translation services

DBT understands the cross-cultural issues and can help integrate your company’s design and manufacturing requirements into your Asian partner’s manufacturing system.