Quality Services
At Nilo Medical Consulting Group, we help clients design, implement, and maintain Quality Management Systems that meet global standards — including 21 CFR 820, ISO 13485, and ISO 14971 — while supporting safe, compliant product development and post-market success. Whether you need to build your QMS from the ground up, integrate design controls, or prepare for an audit, we make quality a strategic advantage rather than a regulatory hurdle.
Integrated Quality, Regulatory, & Clinical Expertise
Because NMCG operates as both a regulatory consulting firm and a boutique CRO, our quality guidance is informed by real-world regulatory interactions and clinical experience. We ensure that your design, verification, and post-market systems are not only audit-ready but strategically aligned with your broader regulatory and clinical goals.
Quality System Development & Optimization
We create and refine Quality Management Systems (QMS) that align with U.S. FDA Quality System Regulation (QSR / 21 CFR 820) and ISO 13485.
Our team helps you design processes that are both compliant and right sized for your organization. Our support includes:
QMS gap assessments and remediation planning
Procedure development and documentation for design, manufacturing, CAPA, complaint handling, and change control
Audit and inspection readiness, including mock audits and 483 response planning
QMS alignment with the upcoming FDA Quality Management System Regulation (QMSR) to ensure readiness before 2026
Learn more about QMSR changes.
Design Controls
Robust design controls ensure that devices are safe, effective, and meet user needs — and they’re required under 21 CFR 820.30 and ISO 13485.
We guide clients through establishing and maintaining clear documentation across every phase of design and development.
Our design control services include:
Development of Design and Development Plans and Design History Files (DHF)
Definition and documentation of Design Inputs and Outputs
Support for Verification and Validation (V&V) planning and execution
Integration of Human Factors Engineering to minimize use errors
Change-control procedures to manage iterative improvements post-market
These activities not only demonstrate compliance but form the foundation for regulatory submissions and ongoing risk mitigation.
Risk Management
We help you build risk management programs that conform to ISO 14971 and FDA expectations. From early hazard identification to post-market surveillance, we ensure your approach is proactive, traceable, and integrated across the product lifecycle. Our services include:
Creation of Risk Management Plans and Reports
Initial risk analysis during design inputs, embedding risk analysis into the design process from the beginning
Failure Modes and Effects Analysis (FMEA) and fault-tree development
Support in identifying hazards, evaluating risks, implementing changes that reduce risks without introducing new hazards, and continuously monitoring and mitigating risks as the design evolves to ensure risk acceptability
Benefit-risk analysis aligned with regulatory and clinical strategy
Integration of risk files into design controls and verification plans
Post-market risk evaluation and complaint trending
Post-Market Quality & Compliance Support
A quality system doesn’t stop at product launch. We help manufacturers maintain compliance and oversight throughout commercialization and beyond. Our post-market support includes:
Adverse event and MDR reporting systems (21 CFR 803)
Complaint handling and CAPA management
UDI & GUDID implementation for device tracking
Periodic internal audits and management reviews
Post-market surveillance and trend analysis
Training and staff education in quality and risk processes
Explore our Regulatory Services for submission and post-market strategy integration.