With quality, control and documentation procedures fully integrated into all of our disciplines, PDT was among the first ISO 13485 certified product development firms in the world. Our teams follow 60601 guidelines for efficient regulatory agency and Ministries of Health approval, and through extensive input and output design documentation can help support all FDA submission opportunities. Integrated risk assessment / FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) and verification / validation testing are essential tools we can assist with to see your program through to production, including complete support in the selection and design transfer of your device to FDA approved Contract Manufacturers.
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