Systems Engineering
Technical Leadership & Documentation
Driving Alignment from Concept to Release
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.
DHF Development
Built Right - Documented Intelligently
We help MedTech startups and device developers build Design History Files (DHF) that stand up to audits and accelerate approvals. Our team aligns technical documentation with regulatory expectations from day one avoiding costly reworks later. Count on a streamlined, compliant DHF foundation that supports your device’s lifecycle from concept to market.
Risk Management
& Design Controls
Controls that Ensure Safety and Compliance
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.
Requirements Definition & Traceability
Tracking Every Step
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.
Verification Strategy & Planning
Mapping the Path to Proven Results
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.
Labeling and IFU
User-Facing Information
We offer services to help ensure that your product’s labeling and Instructions for Use (IFU) meet the latest standards set by regulatory authorities such as the FDA, CE Mark, and international agencies. This includes updating your product's current labeling or starting completely from scratch. Our team can help you develop user friendly labeling material that meets the strict standards of regulatory bodies.
Architecture Definition & Interface Management
Designing How it All Fits Together
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.
CSV & Tool Validation
Confident Compliance
We specialize in Computer System Validation (CSV) and tool qualification tailored for MedTech startups and device developers. Our team ensures your digital tools and software systems meet FDA, EU MDR, and ISO standards from the start. With a proven, scalable approach, we help you accelerate development while maintaining regulatory confidence.
We specialize in Computer System Validation (CSV) and tool qualification tailored for MedTech startups and device developers. Our team ensures your digital tools and software systems meet FDA, EU MDR, and ISO standards from the start. With a proven, scalable approach, we help you accelerate development while maintaining regulatory confidence.