Technical Leadership & Documentation
Design reviews, architecture documentation, labeling content, and system level records are maintained with a focus on clarity and traceability. Supporting materials such as Design History File artifacts, computer software validation, and tool validation packages are prepared to meet FDA and EU regulatory standards.
Systems Engineering
Requirements Definition & Traceability
Clear, testable, and risk based requirements form the foundation of any successful product. These are developed in alignment with user needs and regulatory expectations, then traced through verification to support Design History File documentation and quality audits.
Architecture & Interface Management
System architecture defines how hardware, software, and data layers interact across the product. Interface specifications are managed across teams and subsystems to ensure seamless integration and eliminate downstream disconnects during verification or manufacturing transfer.
Risk Management & Design Controls
ISO 14971 compliant risk management is integrated early and maintained throughout the lifecycle. Risk controls are linked directly to requirements, labeling, instructions for use, and training documentation to ensure safety and compliance from design through postmarket support.
Verification Strategy & Planning
Verification efforts are guided by structured plans that tie directly to system requirements. Protocol development, traceability matrices, and planning for labeling and instructions for use validation ensure regulatory expectations are met across engineering disciplines.
Multidisciplinary Integration
Alignment between mechanical, electrical, software, and clinical teams is maintained through consistent communication, shared specifications, and structured reviews. This cross functional coordination keeps technical execution on track with safety, usability, and regulatory goals.