Medical Device Design & Manufacturing

PDT understands the challenges our clients face with new product development. Our team appreciates the need to integrate front-end creative insight into the procedural rigors of medical device design, development, and contract manufacturing. PDT was among the first ISO 13485 certified product development firms in the world with quality, control, and documentation procedures fully integrated into all disciplines. Astronics expanded its ISO 13485 certification for contract manufacturing.

PDT follows 60601 guidelines for efficient regulatory agency and Ministries of Health approvals. Through extensive design documentation, our team can support all FDA submission opportunities. Integrated risk assessment, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Verification & Validation (V&V) testing will guide your program through production with complete support in design transfer to our local 167,000 square foot manufacturing facility.