Manisha joined Triple Ring Technologies with an in-depth understanding of ISO 13485 Medical devices, Quality Management Systems and Food and Drug Administration’s Quality System Regulations (QSR). She has expertise in establishing Quality Management Systems and ensuring compliance with regulatory standards. Manisha’s experience spans directing development and implementation of QMS related policies and procedures throughout the organization. She has written design verification protocols, run experiments/tests and wrote reports for medical devices. Additionally, Manisha conducts internal and external audits and creates specialized in-house training. Manisha’s academic career included projects such as: developing self-regulated drug delivery devices, working on MEMS technology for treating Glaucoma, and designing a neural prosthesis that automatically controls the symptoms of Parkinson’s disease.
Manisha holds a Bachelors of Engineering in Chemical Engineering from Sarvajanik College of Engineering Technology (S.C.E.T.) in India and a Masters in Biomedical Engineering from University of Southern California. She is also an active member of American Society for Quality (ASQ) and serves as Chair for the ASQ Biomedical Northern California Discussion Group.