TC SMART

Noida Sector 63 H-Block D-45 Uttar Pardesh tcsmarttechnology@gmail.com +91-7065122884

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.

Contact Us Now
Engineering Health. Enabling Trust

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.

Contact Us Now