Medical Device Firmware Development

Full-service medical device design and development including conceptual design, complex part engineering, and regulatory documentation. Supports ISO 13485 and ISO 14971 compliant development from concept through commercial production.

Tailored medical device engineering and manufacturing service integrating R&D, design validation, and certified production in ISO 7-8 cleanrooms for research institutions and medical companies.

Comprehensive medical device consulting services covering design control, risk management, regulatory compliance (MDR, MDSAP), quality management systems (ISO 13485), and market introduction support. Services include mechanical design, FEA analysis, prototyping, DHF documentation, UDI implementation, and EUDAMED registration to facilitate product development from concept through global commercialization.

Engineering and regulatory consulting for safety-critical medical device development, including system architecture design, quality management, regulatory affairs support, and comprehensive testing and optimization services.

End-to-end medical device development services covering electronics, mechanics, optics, software, and firmware engineering. Includes requirements management, system architecture analysis, and component selection. Supports product development from initial concept through scalable production.

Complete medical device development services from initial concept through certified product and mass production. Includes design, engineering, regulatory compliance support, and manufacturing expertise.

Custom diagnostic product development services for medical device companies and healthcare organizations. Leverages in-house expertise in autoimmune, infectious and therapeutic testing assays. Operates under ISO 13485:2016 quality standards with full documentation and validation support.

Comprehensive R&D and design development services for disposable and non-disposable medical devices. Includes concept-to-production support with ISO 13485 compliance and ISO 8 clean-room manufacturing capabilities for customized device solutions.

Contract development and manufacturing services for microfluidic chips, lab-on-chip devices, and flow cell consumables in glass, polymer, and silicon. Supports diagnostic and analytical applications from prototype through pilot production. ISO 9001 and ISO 13485 certified.

Engineering and design services for medical device development, including co-design collaboration, material selection, design for manufacturability (DFM), design for assembly (DFA), industrialization, and validation support. Specialized expertise in fluid control solutions for medical applications.

Embedded software and electronics design services for medical devices, including firmware development, hardware design, and regulatory compliance support. Services encompass risk analysis, FMEA documentation, and design support to ISO 13485 and ISO 14971 standards for device manufacturers and developers.

Medical device design and development services supporting product conceptualization through regulatory compliance. Encompasses technical feasibility analysis, design optimization, and documentation preparation for medical device registration. Supported by ISO 9001 and ISO 27001 certifications and laboratory testing capabilities including electromagnetic compatibility, safety, environmental testing, and microbial analysis.