Why Customization Is Required

Standard products may not fully address the procedural, anatomical, or equipment-specific requirements encountered in clinical practice.

Common challenges include dimensional mismatch, insufficient torque response, limited device compatibility, or suboptimal navigation performance.

Customization enables alignment with specific procedural workflows, brand positioning, and regulatory market requirements.

Custom Guidewire & Catheter Manufacturing

Our solutions cover multiple clinical areas, including:

• Vascular Access

• Urology

• Gastroenterology

• Peripheral Vascular

• Cardiovascular

• Neurovascular

  
  

We provide structured OEM/ODM collaboration models aligned with regulatory and quality system requirements.

What Can Be Customized?

We offer extensive customization options tailored to clinical performance, device functionality, and brand requirements.

Guidewire Customization Options

• Length (e.g., 40–300 cm)

• Coating Type (Hydrophilic / PTFE)

• Core Wire Stiffness

• Tip Flexibility & Shape (Straight, J-tip)

• Radiopaque Markers (number and position)

• Outer Diameter (e.g., 0.018", 0.035")

• Packaging Style (Single-use or bulk)

Catheter Customization Options

• Diameter & Length (Fr/mm)

• Material (PU / PE / PTFE)

• Tip Design (closed tip, side holes)

• Connector Type (Luer lock, custom fitting)

• Radiopaque Marking Options

• Color and Identification Marks

Brand & Packaging Customization

• Label, IFU, and packaging aligned with brand requirements

• Multi-language documentation

• Barcode / QR integration

• Sterile packaging or neutral bulk packaging options

  
  

Example: A Zebra guidewire may be configured with a hydrophilic distal segment and increased proximal shaft stiffness to optimize navigation in complex urinary procedures.

Structured Customization Workflow

Our development process integrates design control and regulatory compliance at each stage:

1. Product Concept Consultation - Definition of technical specifications and intended market requirements.

2. Design & Risk Management - Risk analysis, mitigation planning, and design control documentation.

3. Prototype Development & Testing - Design verification and validation (V&V).

4. Documentation & Regulatory Support - Design History File (DHF) and regulatory submission support.

5. Mass Production & Delivery - Manufacturing under ISO 13485-certified quality management system with batch traceability.

6. Post-Market Monitoring - Complaint handling, vigilance reporting, and performance monitoring.

OEM / ODM Collaboration Models

Hainwise provides flexible cooperation models:

• OEM Services - Private labeling of validated product platforms with customized packaging and documentation.

• ODM Services - Full product development from concept to production, including structural design, material selection, prototyping, validation, and manufacturing transfer.

Manufacturing & Quality Assurance

All customized products are manufactured under ISO 13485:2016-certified facilities and aligned with global regulatory frameworks.

Each product is supported by traceability systems, verification records, and regulatory-ready documentation.

Certifications & Regulatory Readiness

• ISO 13485:2016 Certified QMS

• FDA Establishment Registration

• Certificate to Foreign Government (CFG)

• EU MDR 2017/745 documentation in progress

• Regulatory support files for country-specific submissions

Vigilance & Post-Market Services

• Complaint reporting and escalation system

• Adverse event investigation

• Medical device vigilance integration

• Trend analysis and safety reporting

• Periodic Safety Update Reports (PSURs)

• Corrective and Preventive Actions (CAPA)

Contact for Customization

For OEM and customization inquiries, please contact our technical team to discuss project requirements.

Email: info@hainwise.com
Submit Customization Form