ISO 13485: Excellence Beyond Medical Devices

Variscite, a leading global provider of Systems on Module (SoMs), has been at the forefront of embedded solutions for nearly two decades. As an NXP Platinum Partner, Variscite has built a strong and enduring relationship with NXP, leveraging their advanced processors to deliver scalable and high-performance SoMs.

This partnership enables Variscite to align with NXP's commitment to quality and innovation, ensuring that every product meets the highest standards of reliability and performance. With a diverse portfolio that includes SoMs built with NXP's i.MX 6, i.MX 7, i.MX 8 and i.MX 9 series processors, Variscite continues to provide cutting-edge solutions for various industries. The choice of an ISO 13485-certified System on Module (SoM) supplier presents distinct operational advantages that, while originating in medical device manufacturing protocols, extend substantially beyond their initial scope. Whereas ISO 9001 maintains its position as the predominant quality management framework within the SoM industry, ISO 13485 implements supplementary layers of validation protocols and control mechanisms that significantly enhance quality assurance capabilities. These sophisticated enhancements, though initially conceived for medical device manufacturing, demonstrate remarkable efficacy across all projects demanding elevated reliability standards. Unlike ISO 9001, which emphasizes customer satisfaction and continuous improvement, ISO 13485 focuses more specifically on risk management, comprehensive documentation and tight process control throughout the product lifecycle.

Design for the future. To find more ISO 13485-certifieed SoMs from our trusted partner, Variscite. Visit NXP's Partner Marketplace.

Supplier Management: Delivering Consistent Quality

Within the framework of ISO 13485, supplier oversight encompasses comprehensive evaluation protocols and continuous monitoring mechanisms, establishing a robust foundation for maintaining consistent component quality throughout the supply chain. The choice of suppliers involves a multi-faceted assessment process, evaluating their technical capabilities, quality management systems and production capacity against predetermined performance metrics and industry standards. Detailed records of approved suppliers and their performance evaluations ensure a reliable supply chain, significantly reducing risks. Although these practices are critical in medical device production, their benefits are universal. By ensuring component quality from the outset, manufacturers minimize the likelihood of production issues, enhancing long-term reliability across all applications.

Proactive Risk Management: Addressing Problems Before They Arise

ISO 13485's comprehensive risk management framework encompasses all phases of product development, from initial conception through end-of-life support. Within medical device manufacturing contexts, this framework necessitates thorough analysis and validation of all modifications, including firmware updates, establishing multiple verification checkpoints before implementation to preempt potential safety concerns. This methodical approach yields substantial benefits across diverse applications, particularly in scenarios where SoMs must maintain optimal performance under challenging environmental conditions. For instance, rigorous validation of thermal performance, electromagnetic compatibility and long-term reliability helps prevent expensive system failures. This evidence-backed approach enables manufacturers to detect and mitigate potential problems during development, ensuring smoother production phases.

Detailed Documentation: Strengthening Traceability and Accountability

ISO 13485 mandates an exhaustive documentation protocol that spans the entire product lifecycle, encompassing everything from initial conceptualization through sustained long-term support. This systematic approach to record-keeping establishes comprehensive component traceability and modification history, providing an invaluable framework for addressing quality concerns throughout the product's lifespan. For example, firmware updates or changes in component sourcing must be documented and validated, allowing manufacturers to respond quickly to quality issues. The implementation of robust traceability mechanisms facilitates precise recall procedures when defects are identified, thereby minimizing operational disruptions while ensuring swift resolution of quality concerns. This sophisticated documentation framework demonstrates particular efficacy in complex systems beyond medical applications, where systematic tracking becomes crucial for maintaining operational integrity. When investigating performance issues, engineers can trace root causes more effectively using detailed records of environmental tests, component histories and prior system modifications. The result is faster debugging and more efficient maintenance over time.

Extending ISO 13485 Beyond Medical Applications

The partnership with an ISO 13485-certified SoM provider yields substantial operational advantages across diverse industrial sectors, extending well beyond traditional healthcare applications. For example, Variscite, one of the few SoM manufacturers certified to this standard, demonstrates its commitment to outstanding quality through:

• Exhaustive testing that ensures performance across a wide range of conditions
• Full traceability that aids in troubleshooting and maintenance
• Rigorous quality control measures that address issues early in production
• Data-driven decision-making based on continuous monitoring

ISO 13485 offers more than regulatory compliance; it provides a structured approach to achieving exceptional quality. Building upon ISO 9001's established framework, this certification introduces enhanced precision and reliability mechanisms that prove particularly valuable in mission-critical applications. Engineering teams engaged in embedded systems development can leverage the comprehensive quality assurance protocols of certified SoM providers like Variscite to achieve superior reliability standards while minimizing project risks throughout the entire product lifecycle. As an NXP Platinum partner, Variscite leverages i.MX 9, i.MX 8, i.MX 7 and i.MX 6 processors to deliver SoMs that offer diverse processing capabilities while adhering to validated quality standards.

Brighter together: Partnerships that Drive Innovation

By combining NXP's drive for innovation with Variscite's expertise in SoM design and manufacturing, this partnership ensures that customers receive state-of-the-art solutions backed by industry-leading quality standards. NXP enables Variscite to achieve ISO 13485 compliance thanks to its long-term support, reliability documentation and security helping to meet certification requirements efficiently. Key factors include:

Long-Term Product Availability and Lifecycle Management

• NXP provides long product life cycles ensure medical device manufacturers can maintain compliance with regulatory requirements for extended periods
• Many NXP processors within the i.MX portfolio offer 10-15 years of availability, which is crucial for medical devices that require long-term stability

High Reliability and Safety Features

• NXP's System-on-Chip (SoC) solutions integrate hardware security features, error correction and redundancy, essential for medical applications
• These processors meet stringent electromagnetic compatibility (EMC) and safety standards, aligning with ISO 13485 requirements

Validated Software and Documentation Support

• NXP provides extensive software validation, medical-use reference designs and Board Support Package (BSP) support
• Official compliance documentation, including Failure Mode and Effects Analysis (FMEA), risk assessments and validation reports, simplifies ISO 13485 certification for manufacturers

Medical-Specific Processors and AI Capabilities

• NXP processors support NPU accelerators for AI and machine learning (ML) used in several healthcare applications, aligning with modern ISO
• Features like low-power operation, real-time processing and advanced connectivity (Wi-Fi, Bluetooth, Ethernet) make NXP ideal for portable and embedded medical devices

Clinical Regulation (FDA and EU) for Cybersecurity

• Many NXP processors, such as the i.MX 8 and i.MX 9 series support NXP's EdgeLock® Secure Enclave to enhance medical device security, including: hardware root of trust, secure boot and anti-rollback, tamper detection and response, cryptographic acceleration, key management and secure storage
• EdgeLock SE050 and the latest EdgeLock SE052F Secure Elements provide end-to-end security for connected medical devices, helping meet clinical regulation for cybersecurity thanks respectively FIPS 140-2 and FIPS 140-3 global security standards

Learn more about NXP's partnership with Variscite and browse through our catalog of SOMs and other solutions for your next embedded design.