In sectors where product reliability, long lifecycle and regulatory compliance are essential, such as Medical & Healthcare, Railways & Transport, Avionics & Aerospace, High-Tech mobility and Automation & Energy, material traceability is not just a functional requirement, but a strategic infrastructure. Within Elemaster Group, it is fully embedded in the design, production and validation workflow, particularly through the activities carried out by Eletech, the lead company of the International Design Centres (IDCs), Research & Development division of Elemaster Group.
Rather than being a standalone process, traceability intersects with every stage of the ODM journey, from the bill of materials definition to testing, certification and lifecycle management. This approach ensures not only product reliability, but also greater predictability, transparency and resilience in responding to field issues, obsolescence and compliance audits.
A foundation for regulated innovation
The industries served by Elemaster, including Medical & Healthcare, Railways & Transport, Avionics & Aerospace, Automation & Energy, and High-Tech Mobility, are subject to some of the most stringent international regulations, such as ISO 13485:2021, EN 50155:2017, AS/EN 9100:2018, IEC 60601-1:2005+A1:2012, and the MDR (EU Regulation 2017/745). In these contexts, the traceability of materials and components is a prerequisite for CE Marking, quality audits and post-market surveillance.
Eletech ensures that every component used in product development and manufacturing is tracked throughout its lifecycle. The traceability infrastructure supports:
- Identification of supplier batches and lot codes used in PCB assemblies and enclosures
- Documentation of process parameters, test results, and certification steps for each unit
- Mapping of firmware/software releases and configuration changes over time
This granular documentation is essential when preparing technical files for notified bodies or responding to non-conformities. By providing complete traceability, Elemaster reduces regulatory risk and accelerates time-to-certification for its Customers.
Integrated traceability from design to testing
What makes Elemaster’s approach unique is the integration of traceability into the entire ODM process, beginning at the early design stage. Through the adoption of Design for Testability (DFT) principles, Eletech ensures that every product is designed not only for functionality and manufacturability, but also for verifiability and documentation.
This means that:
- Each critical parameter is traceable through embedded test protocols and validation results
- Component choices are aligned with compliance and lifecycle constraints, enabling early obsolescence risk monitoring
- Custom test systems developed internally (such as the ELETEST platform) ensure high repeatability, precision and data retention during ICT and FCT phases
All this data is retained and referenced during later phases, including failure analysis, maintenance planning, or requalification of systems with updated parts or software.
Supporting obsolescence management and lifecycle extension
As documented in the description of Phase 6 and Phase 7 of Eletech’s ODM process, traceability plays a pivotal role in lifecycle support. In sectors where devices remain operational for decades, the ability to track and retrieve historical component data enables:
- Targeted Last Time Buy strategies for obsolete parts
- Controlled substitution of components with new, validated alternatives
- Proactive requalification or recertification without full redesign
In case of field anomalies, 3D X-ray inspections, thermal imaging, and microsection analysis can be correlated with production and sourcing records, offering a precise understanding of the issue’s origin. This accelerates corrective actions and ensures uninterrupted regulatory compliance.
Operational and strategic advantages
The benefits of an internal, accredited and fully integrated traceability system go far beyond documentation. As highlighted in the section “Predictability, traceability and cost control”, this infrastructure allows Elemaster Group to:
- Reduce dependency on external labs and third-party certifications
- Accelerate iteration cycles during prototyping and industrialisation
- Guarantee full data consistency across product families and updates
- Optimise costs over the entire product lifecycle, especially in multi-market compliance scenarios
In complex systems, such as hospital equipment, onboard train electronics or aerospace subsystems, the traceability of components, testing routines and design revisions is key not only for risk reduction but for long-term business continuity.
Traceability as enabler of sustainability and global market access
In addition to regulatory and technical implications, traceability is becoming increasingly relevant in addressing environmental and ethical sourcing requirements. Global frameworks and customer expectations now demand transparency regarding the origin and composition of electronic components.
Elemaster’s integrated system allows Customers to respond to these requests, facilitating:
- Lifecycle assessment and carbon footprint tracking
- Compliance with extended producer responsibility (EPR) schemes
- Alignment with international sustainability regulations in procurement
In this sense, traceability supports not only product qualification, but also brand reputation, market differentiation, and access to public tenders or sustainable procurement programmes.
Traceability as industrial infrastructure
In the world of ODM-EMS, traceability is more than a compliance tool, it is an invisible infrastructure that underpins every reliable, certifiable and sustainable electronic product. Through Eletech’s capabilities, Elemaster Group embeds this infrastructure into the heart of its operations, transforming documentation into a driver of trust, performance and resilience.
As markets evolve and regulatory demands intensify, companies that integrate traceability as a core design and production principle, rather than a post-hoc obligation, will be best positioned to innovate, scale, and endure.