OPERON BUILDNEXT
Medical Device Design & Development from Concept to Market
Take the next step
Operon BuildNext
New Product Design & Development Service Portfolio
Concept-to-Prototype Design
Translating ideas into structured product concepts
Early-stage feasibility and design planning
Rapid prototyping aligned with intended use
CAD Modeling & Design Refinement
Detailed CAD modeling and drawings
Design optimization for performance and manufacturability
Iterative refinement based on testing feedback
Usability Engineering
User needs analysis and intended use definition
Human factors engineering
Minimizing use errors and improving user experience
Design Validation & Documentation
Verification and validation planning
Design History File (DHF) development
Compliance with ISO 13485 Clause 7.3 & FDA 21 CFR 820.30
Support for regulatory submissions
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
150+ Medical Devices Designed & Developed
Diagnostics, Disposables & Electromechanical
Expertise in ISO 13485 & FDA 21 CFR 820.30 Design Controls
End-to-End Support from Concept to Commercialization
From facility design to audit-ready compliance – we design GMP-compliant manufacturing facilities aligned to regulatory and operational requirements. By integrating cleanroom zoning, utility planning, and workflow optimization, we enable efficient operations and audit-ready compliance from day one.
Operon New Product Design & Development Advantage
Regulatory-compliant plant layout design that ensures operational efficiency, cleanroom readiness, and audit preparedness for medical device manufacturers
Design controls aligned with global regulations
Strong focus on usability & patient safety
Seamless transition from prototype to manufacturing
Integrated regulatory & quality expertise
You Might Also Be Interested in
frequently asked questions
What is Medical Device Design & Development?
Medical Device Design & Development is the process of transforming an idea into a safe, effective, and market-ready medical device. It includes concept development, engineering design, prototyping, verification, validation, regulatory documentation, and manufacturing readiness while ensuring compliance with applicable regulatory standards.
What services are included in Medical Device Design & Development?
Our services include product concept development, industrial design, CAD modeling, engineering design, prototype development, design verification and validation, usability engineering, risk management, Design History File (DHF) preparation, design transfer, and regulatory documentation support.
Which regulatory standards are considered during product development?
Our development process aligns with internationally recognized standards and regulations, including ISO 13485, ISO 14971 for risk management, IEC 60601 where applicable, FDA Design Controls, and other country-specific medical device regulatory requirements.
Can you help prepare Design History File (DHF) documentation?
Yes. We assist manufacturers in preparing and maintaining a comprehensive Design History File (DHF), including design plans, design inputs and outputs, verification and validation records, risk management documents, design reviews, and design changes required for regulatory submissions.
What is new product design and development for medical devices?
New product design and development is the process of transforming a medical device concept into a safe, effective, and manufacturable product that meets user needs and applicable regulatory requirements.
Build a Manufacturing Facility That Passes Audits and Performs Efficiently
Talk to a plant layout consultant