New Product Introduction (NPI)
From Concept to Commercialization
New Product Introduction (NPI) at RexMed is a structured and documented process that brings medical device concepts to market through every stage of design, development, validation, and manufacturing.
New Product Introduction (NPI)
What is IT and why is it critical?
This service ensures that the devices introduced into our production lines meet regulatory requirements for safety, effectiveness, and quality, in compliance with ISO 13485 and applicable authorities. NPI plays a key role in enabling a smooth transition from idea to scalable production while maintaining high standards and regulatory readiness.
Key Benefits
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Structured phase-gated process
Covers concept development, design control, validation, manufacturing setup, and launch readiness. -
Regulatory alignment
Complies with ISO 13485 and ensures products meet safety and quality requirements before production begins. -
Dedicated project leadership
A project leader guides each initiative across all gates, fostering cross-functional collaboration and risk mitigation. -
Infrastructure preparation for production
Ensures manufacturing readiness for commercialization. -
Comprehensive lifecycle support
Includes market research, technical feasibility, regulatory strategy, and post-launch planning.
Key Factors
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Ability to manage end-to-end product development
From market needs assessment through to regulatory submission and commercialization. -
Expertise in design control processes
Includes design input/output, verification, validation, and risk management. -
Regulatory strategy planning
Involves device classification and preparation of documentation as required by regulatory agencies. -
Manufacturing process setup
Ensures production processes and supply chain are prepared and documented for launch. -
Post-market support structure
Involves continuous monitoring and design updates based on real-world feedback.
Certifications
RexMed's Competitive Edge
RexMed delivers a documented New Product Introduction process guided by a dedicated project leader for each initiative. This structured approach guarantees alignment between technical development and regulatory compliance. By coordinating cross-functional teams, managing risk, and preparing production infrastructure in advance, RexMed ensures that each product is launched efficiently and responsibly.
Ready to take your device from concept to certified manufacturing?
Schedule a consultation with our NPI specialists.
FAQ
Does the NPI process include post-launch activities?
Yes. The process includes post-market surveillance and design updates based on feedback.
Can RexMed help prepare regulatory documentation?
Yes. The NPI process includes planning and preparation for required submissions aligned with device classification.
What are the typical stages involved in NPI at RexMed?
Market research, concept development, design and development, regulatory strategy, manufacturing setup, product launch, and post-market support.
Is risk management part of the NPI process?
Yes. Risk assessment and mitigation strategies are integrated throughout design and development.
Does RexMed support early-stage development?
Yes. The NPI process includes market research and concept development before design and validation stages.