Shrisakthi Mahalingam

About Shrisakthi Mahalingam

As a Biomedical Engineer with a strong foundation in Quality Assurance & Regulatory Affairs (QA & RA) for medical devices, I am passionate about bridging technology and healthcare to enhance patient safety and product compliance.My technical expertise spans Machine Learning in Healthcare and Medical Device Quality Management. Notable projects include:Thyroid Disease Prediction using ML algorithms, achieving 95% accuracy in detecting thyroid conditions.Thermo-Responsive Varicose Vein Detection & Care, leveraging biomedical innovation for early intervention.I have a strong foundation in ISO 13485:2016, MDR 2017/745, Six Sigma methodologies, and medical device regulatory frameworks. My knowledge extends to telemedicine, anesthesia workstations, and risk management in healthcare technology.

Experience

1. Trainee Ra

   Cistron Systems Private Limited

   Mar 2025 — Present · Chennai, IN

   I’m excited to share my role as a Management Representative (ISO Coordinator) in the medical device industry. My role involves overseeing the Medical Devices Quality Management System (MDQMS) & MDR 2017, ensuring compliance with ISO 13485 standards.Key Responsibilities: Implementing and maintaining ISO 13485 & MDQMS Ensuring compliance with MDR 2017 regulations Conducting internal audits and supporting certification audits Managing ISO documentation and process improvements Acting as a liaison between management, employees, and auditors Promoting a culture of continuous quality improvementI’m passionate about ensuring quality, compliance, and patient safety through effective regulatory and quality assurance practices.Let’s connect and discuss quality management, ISO standards, and medical device regulations!#QualityAssurance #RegulatoryCompliance #ISO13485 #MedicalDevices #MDR2017 #ISOAudits #MDQMS

Education

• Sona College of Technology

  Bachelor of Engineering, Biomedicalmedical Engineering

  2021 — 2025