Product Lifecycle Services
At Nilo Medical Consulting Group, we bridge regulatory expectations with real-world product performance. We support every stage of device development—from concept and design to verification, validation, and usability testing—ensuring your product not only meets global regulatory requirements but performs as intended in the hands of end users.
Integrated Lifecycle Partnership
From initial design inputs to post-market performance, NMCG provides end-to-end guidance to help you document, test, and demonstrate product safety and effectiveness. Our team connects regulatory, clinical, and quality perspectives to streamline your path to market and sustain compliance after approval.
Design Controls & Risk Management
A strong product foundation begins with robust design controls and proactive risk management. We help you establish processes that trace every decision, document every test, and demonstrate how your design meets user needs and regulatory expectations.
Our experts ensure that your design controls (per 21 CFR 820.30) and risk management system (ISO 14971) are fully aligned and audit-ready—from design inputs and outputs through verification, validation, and design transfer. Our support includes:
Development and documentation of Design and Development Plans
Defining and reviewing design inputs based on user needs and intended use
Creation of design outputs and the Design History File (DHF)
Verification and Validation (V&V) planning and protocol development
Integrated risk analysis and mitigation strategies
Change control procedures to maintain product integrity
Cross-functional design reviews for continuous compliance and performance assurance
These controls don’t just check regulatory boxes—they help you anticipate issues early, optimize usability, and build a device that performs reliably under real-world conditions.
Verification & Validation (V&V) Testing
Verification and validation show that the design meets specifications and fulfills its intended use. Our team develops and manages V&V programs that align with FDA and international standards—ensuring your test data withstands regulatory scrutiny and confirms that your device performs as designed. We support:
Test strategy and protocol development aligned with FDA and ISO expectations
Bench and pre-clinical testing coordination, including biocompatibility, mechanical, and performance testing
Verification of design outputs against specifications
Validation of clinical performance and user needs under intended conditions of use
Integration with clinical research services when human clinical data are required
Preparation of summary reports and submission documentation for inclusion in 510(k), De Novo, PMA, or MDR filings
Our regulatory, quality, and clinical teams collaborate to ensure that every test is traceable to risk controls and submission objectives—avoiding costly rework or data gaps later.
Usability & Human Factors Testing
Human factors and usability testing demonstrate that end users can use your device safely and effectively. Our approach—guided by FDA’s Applying Human Factors and Usability Engineering to Medical Devices—ensures that your product design supports intuitive operation and minimizes use errors.
Our services include:
· User interface evaluations and formative usability assessments
· Simulated-use studies that reflect real-world environments and stress conditions
· Summative usability testing for regulatory submission
· Human factors risk analysis integrated with ISO 14971 risk management
· Development of use error mitigation strategies, labeling, and Instructions for Use (IFUs)
· Differentiation and labeling validation for product variants or model types
We tailor test protocols to your device type, user population, and environment—whether it’s a professional-use, home-use, or digital health product.