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ExpertiseUpdated on 14 March 2025

Expertise in Medical Device Development, Telemedicine, and Cybersecurity Solutions

Büşra Ünlü

Biomedical Engineer at Kardinero Medical Systems Inc.

Ankara, Türkiye

About

Kardinero Medikal Sistemler Inc. is a leading company with over 30 years of experience in the design, production, and marketing of medical devices, particularly in the fields of cardiologic diagnostics, remote patient monitoring, and telemedicine. Our expertise spans hardware and software development, regulatory compliance, and cybersecurity solutions for medical technology.

Our Key Expertise Areas:

1. Medical Device Design & Development:

  • Extensive experience in designing and manufacturing PC-based and wireless Bluetooth ECG devices and ECG Stress Test Systems.

  • Strong background in hardware and software integration for medical devices, ensuring seamless data collection and analysis.

  • Development of multi-parameter medical monitoring systems with capabilities for ECG, pulse oximetry (SpO2), blood pressure, and body temperature monitoring.

  • Regulatory expertise with CE and MDR compliance for medical devices.

2. Telemedicine & Remote Patient Monitoring:

  • Pioneering work in wireless ECG and remote patient monitoring solutions, enabling real-time patient data tracking.

  • Expertise in BLE (Bluetooth Low Energy) technology for wearable medical devices.

  • Development of software platforms that integrate mobile, cloud, and server-based medical data analysis.

3. Cybersecurity in Medical Devices:

  • Flexibility in implementing cybersecurity testing and scenarios for medical devices to ensure compliance with industry security standards.

  • Expertise in conducting security assessments and penetration testing for healthcare systems.

  • Strong knowledge in secure data transmission, encryption, and protection of patient information within telemedicine and medical IoT ecosystems.

4. Regulatory Compliance & Certification:

  • Experience in navigating international medical device regulations, including CE-MDR and FDA requirements.

  • Preparation of technical documentation and risk assessments for certification processes.

  • Expertise in quality management systems (QMS) and ISO standards for medical devices.

We are open to collaborating on R&D projects, product development partnerships, cybersecurity testing, and regulatory support for medical devices. If you are looking for an experienced and innovative partner in medical technology, we would be delighted to discuss potential collaborations.

Let’s shape the future of healthcare together!

Field

  • Innovative, Sustainable, and High-Quality Healthcare
  • Artificial Intelligence (AI)-based Tools and Technologies
  • Digital Solutions and Digitalization
  • Digital Health Data

Organisation

Kardinero Medical Systems Inc.

Company

Ankara, Türkiye

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