ISO 13485
Medical device quality management system certification.
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Quality Without Compromise
At SP Medical, quality is embedded in every step of the process. Each guide wire is supported by full traceability and robust documentation, providing a clear, verifiable foundation for compliance and performance.
Quality is not a checkpoint
At SP Medical, quality is not a checkpoint. It is the foundation of how every guide wire is developed and brought to life.
Our approach combines engineering discipline, clinical awareness, and manufacturing control to create solutions that are as robust in production as they are intuitive in use. Every detail is considered, from how the product behaves in the hands of the clinician to how it performs across scalable manufacturing.
This integrated mindset enables us to support complex requirements with clarity and confidence, inviting our partners to move forward with certainty, from early development through to market readiness.
Certificates & standards
ISO 14001
Environmental management system certification.
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Occupational health and safety management system certification.
View certificateISO 45001:2018 (PL)
Occupational health and safety management system certification.
View certificateEU MDR compliance
Technical documentation and PMS support for MDR readiness.
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Compliance & Documentation
Structured Quality & Regulatory Compliance
EU MDR Compliance
SP Medical supports OEM partners, kit packers, and distributors in navigating the evolving requirements of the EU Medical Device Regulation (MDR) through structured documentation, regulatory insight, and proactive lifecycle support.
Our approach is grounded in a thorough understanding of MDR expectations and notified body scrutiny. We ensure that technical documentation is comprehensive, clearly structured, and aligned with Annex II and III requirements, facilitating efficient review processes and reducing regulatory risk.
- Comprehensive technical documentation support aligned with MDR Annex II and III, including device description, risk management, and clinical evaluation inputs.
- Post-Market Surveillance (PMS) frameworks designed to support continuous compliance, performance monitoring, and data-driven decision-making throughout the product lifecycle.
- Regulatory-ready processes and documentation developed to withstand audits and support efficient submissions, updates, and change management.
By integrating regulatory considerations early in development and maintaining a disciplined approach throughout production and post-market activities, SP Medical helps streamline compliance efforts, enhance documentation quality, and support long-term market access.
Our goal is to enable our partners to meet MDR requirements with confidence – backed by robust documentation, transparent processes, and a clear path from initial submission to sustained compliance.
Controlled Cleanroom Manufacturing
SP Medical operates state-of-the-art cleanroom facilities designed to ensure the highest levels of product quality, consistency, and regulatory compliance.
Our ISO Class 8 cleanrooms provide a tightly controlled environment for the manufacturing of precision guide wires, minimizing particulate contamination and safeguarding product integrity throughout the production process.
- Continuous environmental monitoring with data trending and defined escalation protocols.
- Validated coating and packaging processes ensuring consistent product quality.
- Certified operators trained to meet stringent cleanroom standards.
This integrated approach enables SP Medical to deliver reliable, high-performance components that meet the demanding requirements of the medical device industry.
Advanced Manufacturing Technologies
SP Medical leverages a modern and continuously evolving machine park, combining precision engineering with advanced production technologies.
- State-of-the-art equipment ensuring high precision and repeatability.
- Automated and controlled processes supporting consistent product quality.
- Ongoing investment in new technologies to enhance performance and efficiency.
This strong technological foundation enables us to meet the demanding standards of the medical device industry with confidence and flexibility.
Product & Process Validation
SP Medical delivers robust validation frameworks designed to support regulatory compliance and ensure consistent, high-quality outcomes.
- Comprehensive IQ/OQ/PQ validation packages covering critical manufacturing processes.
- Data-driven process control, including statistical analysis and Cp/Cpk performance monitoring.
- Structured change control aligned with ISO 13485 and customer-specific requirements.
Our validation approach provides documented evidence, process reliability, and confidence in every stage from development to full-scale production.
Designed with the Procedure in Mind
SP Medical brings together clinical understanding, engineering expertise, and controlled manufacturing to develop guide wire solutions optimized for anatomical navigation, physician handling, and consistent performance from concept to commercialization.
SP Medical
We design and manufacture high-performance guide wires and dispensers, delivering precision-engineered solutions to OEMs, kit packers, and distributors worldwide.