Design & Development

Research & Development

Hainwise integrates structured risk management throughout the design and development process to ensure product safety, performance, and regulatory compliance.

Each project is led by a dedicated R&D manager overseeing design, verification, validation, production transfer, and post-market monitoring to ensure controlled and traceable development.

Our engineering team specializes in guidewire and catheter technologies, with expertise in:

• Hydrophilic Coating Technology – Continuous, uniform coating with stable performance and scalable production capability

• Electrochemical Milling – Automated, high-precision processing with strong production consistency

Design Control & Quality

Our design process follows established design control procedures, including:

• Risk identification and mitigation planning

• Design verification and validation (V&V)

• Design History File (DHF) documentation

With over a decade of specialized experience in guidewire and catheter development, we are committed to delivering compliant, reliable, and high-performance interventional solutions.