Medical Industry
Trusted Medical Device Manufacturer for Critical Healthcare Applications
Janco Electronics stands as a leading medical device manufacturer with ISO 13485:2016 certification, delivering precision-engineered solutions for Class I and Class II medical devices. With over 60 years of electronics manufacturing expertise, we understand that medical device assembly requires uncompromising quality standards and rigorous compliance protocols that directly impact patient safety and healthcare outcomes.
Our comprehensive medical device assembly services encompass the complete product lifecycle, from initial design consultation through full-scale production. We specialize in complex electro-mechanical systems integration, ensuring every assembly meets the stringent requirements of the medical industry while maintaining the reliability and precision that healthcare professionals demand.
Advanced Medical Electronics Manufacturing Capabilities
Key manufacturing capabilities include:
- Surface Mount Technology (SMT) for high-density medical electronics
- Through-hole assembly for robust mechanical connections
- Mixed-technology PCB assembly combining SMT and through-hole components
- Electro-mechanical box builds for complete medical device systems
- Conformal coating for enhanced environmental protection
- BGA rework stations for precision component-level repairs
Precision Medical Device Assembly Services
Our medical device assembly services leverage decades of experience in handling sensitive medical components. Every assembly technician maintains continuous certification to IPC-A-610 and J-STD-001 specifications, ensuring consistent quality throughout the assembly process.
We provide turnkey medical electronics assembly solutions that include:
- Component procurement and supply chain management
- PCB fabrication coordination
- Final assembly and integration
- Comprehensive testing and validation
- Packaging and logistics coordination
Quality Management System for Medical Manufacturing
ISO 13485:2016 certification demonstrates our commitment to maintaining the most stringent quality standards in medical device manufacturing. This certification requires more detailed documentation and thorough Quality Management System implementation compared to standard ISO 9001 requirements.
Our quality framework includes:
- Process validation for consistent manufacturing outcomes
- Traceability systems for complete component genealogy
- Corrective and preventive action (CAPA) procedures
- Management review processes for continuous improvement
Advanced Testing and Validation Services
Medical device reliability demands comprehensive testing protocols. Our testing capabilities include:
- Flying probe testing for electrical verification
- In-circuit testing for component-level validation
- Functional testing to verify operational parameters
- Environmental testing including thermal chamber capabilities
- X-ray inspection with 2D and 3D imaging capabilities
- RF and microwave testing for communication-enabled devices
Supply Chain Management for Medical Components
Medical device manufacturing requires exceptional supply chain control to ensure component authenticity and traceability. Our procurement team implements comprehensive counterfeit mitigation strategies, working exclusively with authorized distributors and maintaining complete component genealogy records.
Our supply chain services include:
- Component qualification and approval processes
- Obsolescence management for long-lifecycle products
- Inventory management including consigned and bonded programs
- End-of-life planning and component substitution strategies
Partner with Proven Medical Manufacturing Expertise
Choosing the right medical device manufacturer directly impacts product success and patient safety. Janco Electronics combines advanced manufacturing capabilities with proven regulatory compliance, delivering medical devices that meet the highest industry standards.
Our team understands the unique challenges of medical device manufacturing, from initial prototype development through full-scale production. We work closely with medical device companies to ensure manufacturing processes align with design requirements and regulatory expectations.
Contact our medical manufacturing team to discuss how our ISO 13485:2016 certified capabilities can support your medical device development and production requirements. Our commitment to quality, compliance, and manufacturing excellence ensures your medical devices meet the demanding standards of today’s healthcare environment.
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Janco experts are committed to exceeding our customers’ specifications and expectations on every new product