Medical Device Automation including guidewire assembly, straightening and inspection and handling of catheters or similar Class II/III precision devices.
Medical Device Automation
Guide Wire Assembly & Straightening
Machinelab are experts at Guidewire assembly, straightening, coating and handling of coils. We understand that the manufacturing process is challenging and labour intensive. An automation solution must avoid kinking, bending, or micro-scratching of guide wires and protection of coatings.
- Automated core and ribbon loading.
- J-bending and forming
- Heat setting, curing, and annealing
- Laser processing and ablation
- Welding and weld testing
- Band marking, pad printing, and electro-etching
- Coiling, cutting, and stretching
- Robotic and mechanical handling systems (speed and sensitivity optimised)
- In-line inspection (defect detection, colour verification)
Cardiac Stent and Catheter Handling
Our differentiator and unique offering is that we partner directly with our customers Engineering and R&D personnel to provide handling and materials expertise. We have in-house capability and equipment which help to speed up the new product development process and innovate solutions for manufacturing their products.
- Handling of catheters and similar class II/III precision Medical Devices.
- Specialist jigs and fixtures for manufacture.
- Preservation of device geometry.
- ISO 7 / ISO 8 Clean Room Compliance.
- Technical Partner for Product Development and Proof of Concept.
- In-house R&D and Tool Room
- 5-Axis CNC Milling (HAAS & QUASER) and Wire EDM Centre.
Build to Print
At Machinelab, we partner with our customers to build their equipment to their specifications. We provide more than a build-to print service. We assist with parts obsolescence, BOM Legacy, part naming consistency across CAD platforms.
- Gap Analysis of BOMs & Drawings
- Collaborative Development & Improvements
- Electrical Improvements
- Software Additions e.g cycle time, OEE System connectivity.
- Software Version and Legacy Management
- Management of Obsolescence of Control System Parts.
- Assistance with sourcing alternatives for obsolete parts.
- Recommendations for Improvement to wiring, software and tooling.
Quality Management
Medical device manufacturing is becoming more complex, with increasing regulatory scrutiny, greater demand for traceability and data integrity, pressure to reduce time-to-market, growing need for flexible, scalable automation.
- Alignment with ISO 14971 risk-based management,
- Traceability, ISO 13485 awareness.
- Formal Change Control Process.
- Good Documentation Practices. (GDP) Audit Ready.
- Formal Validation and Acceptance DQ & Design Specifications, IQ/OQ, FAT and SAT protocols.