When it comes to the design and development of your device, Pacific Plastics & Engineering is obsessive about accuracy. Once we've completed an analysis of your project's design, all adjustments are exactly and carefully recorded every time a test is completed. We will monitor and identify variations in performance, problems or potential issues.
PP&E is certified by the FDB of California which reports our audit results to the FDA who registers us; PP&E is also registered by Lloyd's Register Quality Assurance (LRQA). All records of your product's performance are maintained in a Tool/Assembly Tracking folder. Inside, we organize all of the project's beginning 3-D modeling or CAD files, draft designs and changes, plus the ongoing meetings that take place between you and all PPE teams regarding your device. Lines of communication are kept open between us through this folder, which is available to you at all times.
Robust internal processes are in place to ensure nothing is missed in any aspect of your project's progress:
- FDA registered
- Tooling/Assembly Progress Reports - to keep you abreast of your project's testing, modifications, certification process, etc.
- Tool Status Reports - for the engineer's information about the mold-making progress
- Project Planning Checklists - an overall failsafe so nothing is overlooked
By keeping careful documentation of your medical device's development, testing and production; we are able to offer you all of the information you will need for certification applications, funding analysis, and other committee reviews. Consistency and accuracy follow each project from start to finish, and for the lifetime of our relationship.
