Consulting in Design History Files

Service Description

- Design History File (DHF) Management: Structuring, organizing, and ensuring compliance of DHFs according to ISO 13485, FDA requirements, and EU MDR, ensuring traceability and design integrity. - Design Change Control and Regulatory Impact Assessment: Analyzing design modifications, managing document updates, assessing regulatory impact, and controlling implementation for seamless compliance. - Design Transfer and Manufacturing Readiness: Facilitating the transition from development to production by aligning validation processes, regulatory expectations, and quality management system requirements. - Gap Analysis and Technical Documentation Update: Identifying document deficiencies, recommending corrective actions, and updating essential files for regulatory audits and approvals. - Risk and Usability Assessment: Performing risk analysis and usability testing to verify compliance with safety, efficacy, and market requirements. This service ensures a structured, compliant, and optimized approach to design documentation, modifications, and product transfers, minimizing risks and improving regulatory success.