At ATL, quality is paramount, both to us and to our customers. That’s why we’ve taken a number of steps to ensure that your custom labels or disposable medical devices project is completed to the highest standards:
- ISO 13485:2003 Registered
- FDA Registered Medical Device Manufacturer
- cGMP Compliant to 21 CFR 210, 211, and 820
Our engineers use the principles of Quality Function Deployment (QFD), FMEA (Failure Modes & Effects Analysis), DOE (Design of Experiments), ANOVA (Analysis of Variance), hypothesis testing, and other preventive quality assurance techniques to provide you with the best optimal design and highest possible conformance quality.
New product development goes through a series of stages to ensure ATL understands your project requirements, foresees any potential process failures and completes any necessary testing and revisions. Click here to view an overview of ATL’s complete new product development and planning process.
ATL not only adheres to FDA regulations, we also exceed them at many levels. For more detailed information on how ATL’s medical devices conform to (or exceed) FDA cGMP at every step in the production continuum, click here for a comprehensive article outlining the process, including an example of 43 quality validation steps.
For help with your next customized labels or disposable medical devices project, contact ATL at 800.444.5144 or fill out this form.