At the process validation stage, we establish that the device specifications conform to user needs and intended uses. We also conduct production readiness builds and finalize the risk management plan and production process documents. Then we file for regulatory approval.
High-level outputs
- Conduct production readiness builds: train staff, run under production conditions
- Finalize all process and quality documents, protocols, and reports
- Prepare and submit 501(k) file, demonstrating to the FDA that the device to be marketed is safe and effective
- Prepare technical file and design dossier for CE Mark (European Union)
Results
We establish process validation and production readiness and produce process performance qualification (PQ) reports. We also finalize the supply agreement and quality agreement. The Product Design team reviews and approves the reports and all other deliverables. At this point we submit regulatory filings and move on to the next phase.
Tools
We use a detailed process validation process—following established standard operating procedures and ISO requirements—to obtain evidence-based validation of your product. We work closely with you to set up and run the production readiness builds, following a comprehensive process that complies with worker safety regulations, quality controls, and input and output validation.
