Medical Device R&D and Regulatory Compliance
Engineering Health. Enabling Trust.
Developing embedded systems for healthcare requires strict adherence to medical standards, patient safety, and quality control. We help you develop and certify medical-grade devices, from prototypes to global launch.
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Healthcare Domain Expertise
Specialized solutions for developing and certifying medical-grade devices with a focus on safety and compliance.
Risk & Usability Engineering (ISO 14971, IEC 62366)
Focused design on patient safety, risk management, and human-centered usability.
IEC 62304-Compliant Software Engineering
Life cycle management for Class A/B/C medical device software.
Biocompatibility, Sterilization & Environmental Considerations
Material selection and sterilization strategies for safe patient interaction.
Clinical Trial Support & Data Logging
Prototyping, logging, and validating hardware for clinical environments.
Post-Market Vigilance & Surveillance Systems
Setup of incident monitoring, compliance reporting, and continuous improvement loops.
FDA & MDR Documentation
Preparation of DHF, DMR, and Technical File for global regulatory approvals.
Develop Trusted Medical Devices with TC Smart Technology
Contact us to learn how our medical device R&D and regulatory compliance expertise can support your healthcare innovations.
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