What We Offer – Nucleux Medical

Design for Excellence (DFx)

Our approach encompasses a set of principles and practices aimed at optimizing product design and process for medical devices to enhance quality, manufacturability, and overall performance.

DFm: Product design for simplifying and optimizing manufacturability during the development phase, or as remediation.
DFa: Product design for optimization of assembly targeting reduced assembly times, lower labor costs, and enhanced product quality.
DFt: Product testing focused in maximizing efficiency, higher quality assurance, and enhanced patient safety throughout product lifecycle.

New Product Development

Nucleux Medical adopts a systematic approach to New Product Development that seamlessly integrates people, products, and processes to meet your objectives.

Prototyping: Development of early device iterations to demonstrate intended functionality and performance for design inputs, product requirements, and usability.
Design Verification: Implementation of comprehensive planning, requirement generation, test method and protocol development to ensure design outputs meet design specifications throughout design verification builds and testing.
Batch Releases: Implementation of comprehensive planning, requirement generation, test method and protocol development to ensure design outputs meet design specifications are verified for production equivalent units.

Quality Assurance

Quality is a core guiding principle for Nucleux Medical. Our approach ensures high quality design and all regulatory-body requirements are met throughout the entire life cycle with patient safety and device performance in mind.

Design Quality Planning: Define clear quality objectives and metrics that align with project goals, regulatory requirements, and user needs in accordance with ISO Standards.
Documentation and Traceability: Develop and maintain a comprehensive Design History File (DHF) that documents the design and development process, including design inputs, outputs, reviews, and changes.
Quality Management System Development: Develop and implement a comprehensive Quality Management System compliant with ISO 13485 and FDA regulations, integrating quality principles into all processes to ensure robust document control.

Human Factors Engineering

By embedding Human Factors Engineering principles into our process, medical devices are designed with the user in mind, promoting safety, effectiveness, and an optimal user experience throughout its lifecycle

Task Analysis: Analyze the workflow and context in which each device will be used, identifying critical tasks, potential challenges, and user interactions to inform design decisions.
Usability Testing and Evaluation: Identify and engage target users to perform specific tasks with the device, collect data on success rates, error rates, and time on task to establish key principles and parameters.
Training and support Materials: Develop clear, user-friendly manuals and guides that provide instructions for device use, emphasizing usability and safety.

Regulatory Affairs

Navigating the regulatory landscape for Class 3 medical devices is critical to ensuring market access and compliance. At Nucleux Medical, we provide comprehensive support for regulatory submissions, including Investigational Device Exemption (IDE), 510(k), and Premarket Approval (PMA).

Regulatory Road Map: Develop a strategic roadmap that outlines the steps needed for successful submissions, including timelines, required documentation, and key milestones.
Pre-submission: Engage with regulatory agencies early to discuss the intended use, classification, and regulatory pathway for the device, ensuring alignment with agency expectations.
Regulatory submissions: Guidance and support for IDE, 510k and PMA submissions through key documentation, data compliance, and quality standards.

Clinical Trial Support

Conducting clinical trials for medical devices is a critical component of bringing your medical device to market. Our approach ensures that trials are conducted efficiently, ethically, and in compliance with regulatory standards, ultimately enhancing the device’s safety and efficacy profile and facilitating successful market entry the first time.