Development and Production of Medical Devices acc. ISO 13485

Custom-designed medical devices manufactured under ISO 13485 certification with integrated research, development, and production quality assurance. Ensures regulatory compliance and validated biomedical performance.

Contract manufacturing and design services for microfluidic devices used in in vitro diagnostics and life science research. Specializes in polymer microfluidic integration, functional coatings, and microarray printing with ISO 13485 compliance. Supports product development from concept through commercial manufacturing for diagnostic consumables and research tools.

Electrospinning equipment manufactured and configured to meet ISO 13485 medical device quality management standards. Systems include documentation and process controls required for regulated medical device production.

Specialized manufacturing services for custom-designed medical devices tailored to specific client requirements. Utilizing advanced production facilities and ISO 13485 certified quality systems. Capable of producing small to medium production volumes with full regulatory compliance.

ISO 13485-certified series production of medical devices with cleanroom facilities, internalized manufacturing processes, and sterilization-ready output.

Contract manufacturing of finished medical devices and complex components for orthopedic, spine, trauma, cardiovascular, and neurovascular applications. ISO 13485 and FDA QSR compliant with precision engineering capabilities and global manufacturing facilities supporting OEM partners from design through production.

Full-scale production services for medical devices from small batch quantities through high-volume manufacturing. Operates under ISO 9001:2015 and ISO 13485:2016 quality management systems.

Complex implant manufacturing combining injection molding, coating, and precision assembly. Engineered solutions for implantable medical devices requiring biocompatible materials and exact specifications. ISO 13485 certified production ensures regulatory compliance and quality standards.

Precision-manufactured medical device components and parts developed, manufactured, and supplied in-house with ISO 13485 certification. Supports various medical instruments and equipment across multiple therapeutic areas.

Full-scale assembly and manufacturing services for complete medical devices and imaging systems in ISO 13485-certified facilities. Services include quality control and regulatory compliance documentation for clinical device production.

Integrated mechanical, electronic and software solutions for medical and diagnostic applications, developed and manufactured according to ISO 13485 standards.

Dedicated manufacturing line for active medical devices with ISO 13485 quality management system compliance and regulatory compliance design development capabilities.