Akriti Singh
Immediate Joiner||Medical Device Complaint Handling Specialist | MR | DXR & C&R Modalities | ISO 13485 | Risk Analysis | CAPA | EU MDR | FDA 21 CFR 820
- Role
- Senior Associate at Wipro
- Location
- Kolkata, WB, IN
- LinkedIn followers
- 500 followers
About Akriti Singh
I’m a Materiovigilance Specialist with 2.5 years of experience in medical device safety and regulatory compliance. My journey started with a degree in Radiology and Imaging Technology, followed by hands-on training in MRI, CT, and quality control. Today, I work as a Senior Associate at Wipro, where I handle global complaints, investigate device performance issues, and ensure compliance with FDA and EU MDR regulations. I’m passionate about complaint handling, risk management, and post-market surveillance because I believe patient safety should always come first. Beyond regulatory reporting, I enjoy analyzing data trends and contributing to strategies that improve device safety and performance.
Experience
Senior Associate
May 2024 — Present
Managed global and regional complaints by gathering data, classifying devices using IMDRF codes, and submitting reports to the FDA via TrackWise. Specialized in handling complaints for diagnostic X-RAY systems. Conducted investigations, including Complaint History Review (CHR), Device History Review (DHR), and root cause analysis, and wrote investigation summaries. Made informed decisions on medical device reporting (MedWatch Form 3500A) following 21 CFR 803 regulations and ISO 13485 standards. Familiar with international standards including MDD, EU MDR, ISO 14971, IEC 62304, and IEC 62366-1.
Education
Brainware University
Bachelor's Degree, Nuclear and Industrial Radiologic Technologies/Technicians
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