Creating Design Controls (URS/DIR, Verification and Validation Planning)

Effective design control is crucial for ensuring that medical devices meet all regulatory requirements and function as intended. At confinis, we assist clients in creating comprehensive design controls, including User Requirement Specifications (URS) and Design Input Requirements (DIR). Our approach ensures that every aspect of the design process is documented and verifiable, providing a clear path from initial concept to final product.

We help clients develop robust verification and validation (V&V) plans, ensuring that each design element is thoroughly tested. This includes defining clear criteria for success and documenting the results in a systematic manner. By integrating these controls, we help ensure that the final product meets all regulatory standards and performs reliably in real-world conditions, thereby reducing the risk of non-compliance and product recalls.