Nishitha Daryn
Medical
Medical
Engineer
About
I am a passionate Medical Electronics student with interests in healthcare, medical devices, and technology. Focused on Medical Device Regulatory Affairs, Clinical Evaluation, Quality Management Systems, and Risk Management, with growing expertise in EU MDR 2017/745, FDA 510(k), ISO 14971, ISO 13485, and Clinical Evaluation Reports (CERs), I am committed to advancing safe, effective, and accessible healthcare technologies.
Achievements
- 2nd Place Cybersecurity MUN Issued by: Ramaiah Institute of Technology Date: 4/9/2015
- Winner of the Lenovo SmarterEd Scholarship Program Issued by: Hindustan Times Date: 1/1/2021
- Award for Balanced Student Issued by: International Baccalaureate and Conselho Nacional de Educacao Date: 11/1/2019
Experience
- -
Founder & Executive Director @ The Tech Society
IN - On-siteSummary:
- Published monthly digital zines on technology and society, focusing on research, technical writing, and editorial review. Organized "The Engineering Blueprint" career workshop series in collaboration with IEEE. Led software and hardware project teams, fostering technical problem-solving and collaboration.
- -
Intern @ Tamil Nadu Centre of Excellence for Advanced Manufacturing - TANCAM
IN - On-siteSummary:
- Developed a VR Medical Anatomy Museum on Unity for immersive learning experiences. Programmed ESP32 robots controlled via a PS4 controller, and worked on a CPR training mannequin equipped with sensors to measure vital parameters.
Projects
Regulatory Affairs : Sample EU MDR - Pulse Oximeter
Comprehensive technical file outlining device design, specifications, and regulatory compliance for EU MDR submission.
- 📄 Device technical file structure
- 🧾 Intended use, Clinial Disease
- ⚙️ Design and manufacturing details
Clinical Evaluation Report assessing clinical safety and performance based on available clinical data and literature.
- 📚 Clinical literature analysis
- 🩺 Safety and performance evaluation
- 📊 Benefit-risk assessment
ISO 14971-based risk management documentation identifying hazards, estimating risks, and implementing control measures.
- ⚠️ Hazard identification and analysis
- 🛡️ Risk control implementation
- 📉 Residual risk evaluation
Formal statement declaring conformity of the device with applicable EU MDR requirements and standards.
- 📜 Regulatory compliance declaration
- ✅ EU MDR conformity statement
- 🏷️ Manufacturer responsibility confirmation
Healthcare Projects
Developed an AI-driven respiratory sound classification system as part of a collaborative four-member engineering team, aimed at supporting preliminary respiratory assessment through digital auscultation.
- 🫁 Lung sound classification
- 📊 MFCC & Mel spectrogram analysis
- ⚕️ SaMD regulatory assessment
- Python
- TensorFlow
A patient database that keeps track of patient details including name, age, gender, blood group, contact info, medical condition, allergies, assigned doctor, and room number.
- 📋 Patient information management
- 🩺 Doctor and room assignment tracking
- 💻 Simple implementation for clinics
- React
- FastAPI
A real-time patient monitoring dashboard showing ECG, blood pressure, vitals, trends, alerts on threshold breaches, upcoming appointments, and patient details.
- 📈 Real-time vitals monitoring
- ⚠️ Alerts on threshold breaches
- 🗂️ Patient details and appointment tracking
- Next.js
- TypeScript
- CSS
A virtual reality first-person walkthrough of a human organ museum built using Unity. Aimed at helping medical students learn anatomy through immersive visualization.
- 🫀 Explore human organs in 3D
- 🧠 Immersive educational experience
- 🎮 Unity-powered walkthrough
- Unity
- C#
Education
Ramaiah Institute of Technology
B.tech Medical ElectronicsIndian Institute of Technology Madras
BSc Data Science
Skills
- Python 4
- C 3
- C++ 3
- Git 3
- GitHub 3
- HTML 3
- CSS 3
- Unity 3
- React 4
- FastAPI 4
- Next.js 4
- TypeScript 4
- CSS 4