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Advancing Medical Electronics Manufacturing:
Precision, Compliance, and Quality with Our Track, Trace & Control Solutions

May 2nd, 2024
By Cogiscan's Experts
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The biotech and medical industries are at the forefront of innovation, constantly evolving to meet the needs of patients and healthcare professionals worldwide. In this ever-advancing landscape, electronics manufacturers face the critical challenge of delivering precision, ensuring compliance with industry standards, and upholding a strong commitment to quality. As a leader in Track, Trace & Control solutions, we’ve been enabled medical-focused electronics manufacturers to meet the demands of this industry for over twenty years now.
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Adhering to ISO13485 with Cogiscan Traceability

One of the pivotal elements for manufacturers is compliance with ISO 13485, a standard that outlines the requirements for a comprehensive quality management system in the design and manufacture of medical devices. Our Traceability software is designed to meet these rigorous standards, providing detailed traceability that supports quality control and mitigates risks, with the capability to reach IPC Level 4 Traceability Standards. Our system tracks comprehensive data for each serialized PCBA and documents in-depth information on all products and materials, as well as process settings. This also includes that every component and sub-assembly is linked to the top-level unit, ensuring the possibility to trace up or down.

Avoiding Warranty Returns and Recalls with Production Control

Our TTC Platform is strategically designed to reduce the number of warranties returns and product recalls—an enormous concern in the medical and biotech manufacturing industry. By implementing rigorous shop floor controls, the platform ensures that products are assembled according to spec on every production run. This accuracy not only reinforces customer trust and satisfaction by delivering reliable and high-quality products but also plays a pivotal role in reducing the financial burden and reputational damage that can result from latent product failures. It’s all about proactively preserving the integrity of manufacturing processes to keep warranty and recall rates to an absolute minimum.
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Active Traceability = Traceability + Control

The Material & Process Applications within our platform do more than monitor; they actively manage and control the production line. By doing so, you can quickly and easily respond to any deviations from process requirements, thereby enabling you, or your CMs, to stop production pre-emptively. This system also considers the critical process related exposure risks inherent to the industry, including temperature fluctuations and humidity levels, and manages those to keep to the highest quality requirements. This ensures that potential defects are addressed before leading to a compromised product, aligning with the stringent standards of the sector and safeguarding the trust placed in these vital electronic products.

LCR Control to Combat Counterfeits Components and Supply Chain Errors

By meticulously checking the inductance, capacitance, and resistance tolerances, our LCR Control module guarantees that each component strictly adheres to the specified parameters. This application helps to safeguard the manufacturing process from counterfeit components getting into production and compromising the integrity of both inventory and the subsequent assembly process. In doing so, you’ll not only uphold the highest standards of product quality but also fortify the trust between you and your clients by ensuring the reliability and authenticity of every component used.
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Safety is Non-Negotiable in Medical & Biotech

When products directly impact human health, an uncompromising approach to safety is paramount. Our Setup & Process Control module is specifically engineered to reinforce this safety-first practice. This comprehensive module validates every facet of the SMT machine setup process, including components, tooling, consumables, as well as the program or recipe. It extends to machine settings and parameters, ensuring that each element aligns with the stringent safety specifications required in these sectors.

Seamless Enterprise Systems Integration: ERP, MES & MOM

Our TTC Platform features an open architecture that simplifies integration with existing systems such as MES/MOM, and ERP. This facilitates a seamless flow of data across all factory levels and operations, ensuring comprehensive interconnectedness without the need for significant system overhauls or downtime.
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In summary, we have cemented our role as a must-have in the challenging arena of medical electronics manufacturing, where the importance of precision and strict compliance with standards such as ISO 13485 cannot be overstated. For over twenty years, our Track, Trace & Control solutions have played a pivotal role in enabling manufacturers to uphold unparalleled standards of quality and safety. Our dedication to the electronics manufacturing industry is unwavering, as we continue to support our partners in achieving excellence during every aspect of production.
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