Quality and Regulatory Submission Support
Risk Management
Design Verification and Validation
Design Verification and Validation
Meeting ISO 14971 and 13485 expectations for a device submission.
Design Verification and Validation
Design Verification and Validation
Design Verification and Validation
Verification of design inputs and validation of user needs.
Production Validation
Design Verification and Validation
Phase Gate - Development
Reducing risk at each stage of the process sometime seem daunting, we can help. Using FMEA to help reduce failures and mitigate risk is important.
Phase Gate - Development
Phase Gate - Development
Phase Gate - Development
Phase gate review to ensure each phase is completed to minimize risk and cost.
Inspection Plans
Phase Gate - Development
Inspection Plans
In process of independent inspection. Inspection plans that tie to the risk management plans.