Engineered to meet the rigorous standards of Spain's Sistema Nacional de Salud (SNS). High-precision biomechanical design for superior patient outcomes.
Spain's healthcare landscape, governed by the decentralized *Sistema Nacional de Salud (SNS)*, demands orthopedic solutions that balance clinical excellence with economic sustainability. With one of the highest life expectancies in the European Union, the prevalence of degenerative disc diseases, spinal stenosis, and osteoporotic fractures in Spain has surged, driving the need for advanced spinal fusion and motion preservation systems.
Spanish orthopedic surgeons in major hubs like Madrid, Barcelona, Valencia, and Seville are increasingly adopting **Minimally Invasive Surgery (MIS)** techniques. MIS approaches minimize soft tissue disruption, reduce post-operative pain, and accelerate patient recovery. Consequently, there is a high-volume demand for low-profile, high-precision pedicle screws, expandable cages, and cervical fixation systems that offer seamless intraoperative handling and absolute biomechanical stability.
As a leading global manufacturer, HBM Medical bridges the gap by delivering top-tier titanium alloy implants that strictly adhere to the new **EU Medical Device Regulation (EU MDR 2017/745)**, ensuring seamless market entry and clinical trust across all Spanish autonomous communities.
How HBM Medical integrates advanced material science with clinical feedback to engineer next-generation spinal systems.
We utilize medical-grade Titanium Alloy (Ti6Al4V ELI) conforming to ASTM F136. This material offers exceptional biocompatibility, high fatigue strength, and a modulus of elasticity closer to human bone, reducing stress shielding.
Our implants undergo advanced anodization and SLA (Sandblasted, Large-grit, Acid-etched) surface treatments. This micro-roughness enhances osteoblast adhesion, accelerating osseointegration and securing long-term implant stability.
Every spinal system is paired with a streamlined, intuitive instrument kit. Designed in collaboration with leading clinical experts, our tools reduce surgical steps, minimize intraoperative time, and enhance surgeon control.
In the medical device industry, trust is built on rigorous compliance. HBM Medical operates under a world-class quality management system certified to **ISO 13485** and **MDSAP**. For our Spanish partners, we provide full regulatory dossiers to support registration with the **AEMPS** (Agencia Española de Medicamentos y Productos Sanitarios).
Our CE certifications under the stringent **EU MDR 2017/745** guarantee that our pedicle screws, rods, and connectors meet the highest safety, performance, and clinical evaluation standards required by European law. We provide complete technical files, clinical evaluation reports (CER), and Post-Market Clinical Follow-up (PMCF) plans to ensure seamless long-term compliance.
By partnering with HBM, Spanish distributors can confidently bid for public hospital tenders, knowing that our regulatory framework is flawless and fully prepared for any audit.
Request Regulatory DossierInside HBM Medical's 30,343 m² state-of-the-art smart manufacturing facility, where technology meets scale.
HBM Medical's manufacturing facility represents the pinnacle of modern medical engineering. Equipped with over **120 high-precision CNC machining centers** (including Swiss-type automatic lathes from Citizen and Star), we achieve tolerances within microns. Our **12 automated production lines** run continuously, ensuring a robust and highly scalable supply chain that can easily buffer global market fluctuations.
Quality control is integrated into every stage of production. With **36 dedicated QA/QC inspectors**, we perform 100% optical and dimensional inspections, coordinate measuring machine (CMM) verification, and rigorous mechanical testing (static and dynamic fatigue testing in accordance with ASTM F1717 and ASTM F2193).
For Spanish procurement managers, this translates to **unrivaled cost-efficiency, consistent product quality, and guaranteed lead times**, mitigating the supply chain bottlenecks currently affecting many European manufacturers.
Explore our complete range of CE-certified polyaxial screws, monoaxial screws, and titanium rods engineered for posterior internal fixation.
At HBM Medical, we understand that every market has unique requirements. We offer comprehensive **OEM and ODM services** tailored to the specific needs of Spanish medical device brands and distributors. Whether you require customized laser marking, specialized screw thread designs, or custom-designed surgical instrument trays, our R&D team is equipped to deliver.
Our team of **31 R&D engineers** (including post-graduates and doctorates) works closely with your product managers to translate clinical requirements into high-performing medical devices. We support sample processing, graphic processing, and customized on-demand manufacturing.
With over **10 years of exporting experience** to highly regulated markets, we handle all aspects of international logistics, custom clearance, and sterile packaging validation, ensuring a hassle-free supply chain directly to your warehouse in Spain.
Discuss OEM/ODM ProjectEssential information regarding regulatory compliance, manufacturing standards, and logistics for Spanish procurement professionals.
Enhance your clinical offerings and secure your supply chain with HBM Medical's EU MDR compliant, high-precision spinal systems.
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