Aniket Birwadkar is an Associate, in AlvaMed’s Compliance group. He supports regulatory, quality, and process improvement initiatives with a focus on integrating advanced technology solutions into medical device compliance frameworks.
Aniket has experience in U.S. and international regulatory standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, and EU MDR. At AlvaMed, Aniket works on AI-driven projects that strengthen quality systems, improve compliance processes, and enhance regulatory document traceablility.
Aniket’s qualifications and accomplishments include:
- Conducting detailed research and analysis of FDA, EU MDR, and international regulations to support client quality and compliance initiatives.
- Developing and maintaining compliance documentation, ensuring consistency across processes and audit readiness.
- Supporting risk-based and data-driven quality strategies, including FMEA and root cause analysis.
- Contributing to the design and implementation of an AI-driven labeling tool for regulatory documentation automation.
- Collaborating with cross-functional teams to ensure adherence to ISO 13485 and 21 CFR 820 requirements.
- Managing nonconformance reports (NCMRs) and CAPA activities using structured problem-solving tools.
Prior to joining AlvaMed, Aniket gained experience at XcelLance Medical Technologies and Mahatma Gandhi Mission’s Hospital in India, where he strengthened his expertise in quality system management, process validation, and biomedical equipment maintenance.
Aniket holds a Master of Science in Bioengineering (Biomedical Devices and Bioimaging concentration) from Northeastern University and a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai. He also holds a Lean Six Sigma Green Belt Certification.
