Robling Medical
Contract manufacturer focused on medical devices and life sciences, offering end-to-end services from design-for-manufacturing and validation through sterile disposable production, electro-mechanical assembly, packaging, sterilization, and quality/regulatory support. Operates an ISO 13485:2016 certified facility with multiple ISO Class 8 cleanrooms.
Industries
N/A
Nr. of Employees
small (1-50)
Robling Medical
90 Weathers Street, Youngsville, NC 27596, USA
Patents
Services
Design input capture, prototyping, DFM/DFA, material and tooling selection, and preparation for regulatory submissions.
Management of equipment/tool/process validation, product and packaging testing, shelf-life and distribution simulation, and sterilization validation.
Prototype through full-scale manufacturing of sterile single-use disposable medical products with joining, assembly, inspection, and cleaning operations.
PCB processing, cable/harness assembly, wiring and soldering, system integration, serialization, and functional testing with service/repair support.
Form-fill-seal operations, rigid tray packaging, inline printing, regulatory labeling, kit assembly, procurement, and inventory management.
Management and oversight of sterilization processes and validations for EtO, gamma, and E-beam sterilization.
Design input capture, prototyping, DFM/DFA, material and tooling selection, and preparation for regulatory submissions.
Management of equipment/tool/process validation, product and packaging testing, shelf-life and distribution simulation, and sterilization validation.
Prototype through full-scale manufacturing of sterile single-use disposable medical products with joining, assembly, inspection, and cleaning operations.
PCB processing, cable/harness assembly, wiring and soldering, system integration, serialization, and functional testing with service/repair support.
Form-fill-seal operations, rigid tray packaging, inline printing, regulatory labeling, kit assembly, procurement, and inventory management.
Management and oversight of sterilization processes and validations for EtO, gamma, and E-beam sterilization.
Expertise Areas
- Design for manufacturing and assembly (DFM/DFA)
- Validation and verification (V&V) testing
- Regulatory compliance and submission support
- Sterile disposable manufacturing
Key Technologies
- Ultrasonic welding
- Heat sealing of medical polymers
- Radio-frequency (RF) sealing and tipping
- Adhesive bonding (UV, solvent, epoxy)
News & Updates
Exhibited at MD&M West (Booth 670) to discuss manufacturing and development services.
Planned attendance at MD&M West (Booth 2126) to engage with OEMs about device development and manufacturing.
Participation at Medical Technology Ireland to connect with industry stakeholders.
Discussion of company partnership approach emphasizing responsiveness and trust.
Overview of services connecting development and manufacturing to accelerate commercialization.
Article describing combined manufacturing capabilities for disposable components and electro-mechanical systems.
Exhibited at MD&M West (Booth 670) to discuss manufacturing and development services.
Planned attendance at MD&M West (Booth 2126) to engage with OEMs about device development and manufacturing.
Participation at Medical Technology Ireland to connect with industry stakeholders.
Discussion of company partnership approach emphasizing responsiveness and trust.
Overview of services connecting development and manufacturing to accelerate commercialization.
Article describing combined manufacturing capabilities for disposable components and electro-mechanical systems.