Design & Development
Designing safe, effective medical devices from concept to market
The design and development process is a core element of bringing safe and effective medical devices and IVDs to market. Our team provides expert guidance throughout the entire design lifecycle.
What is design & development?
Design and development is the foundation for bringing innovative and compliant medical devices (MDs) and in vitro diagnostic devices (IVDs) to market. It encompasses the entire lifecycle of a product, from initial concept to final validation, ensuring that the product is safe, effective, and meets all regulatory requirements.
Whether you are beginning the process or are an established manufacturer requiring assistance with evaluating design changes and how these impact your regulatory submissions, we can help you identify the optimal solution.
How we support you
Our team of specialists will guide you through the design and development process, ensuring that your product meets the highest standards of quality and safety.
Concept development
Support from initial product concept through to design validation.
Design documentation
Comprehensive design history file and documentation support.
Risk management
Integration of risk management throughout the design process (ISO 14971).
Verification & validation
Planning and execution of design verification and validation activities.
Why QbD Group
Your trusted partner
Our specialists guide you through every phase of the design and development process.
Deep expertise in MD and IVD design controls.
Proven approach aligned with ISO 13485 and applicable regulations.
Experience across all device classifications and risk classes.
End-to-end support from concept through post-market design changes.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.