Our Solutions Delivery Specialist, Nikita Angane, explains how to build a strong Quality Management System for your Software as a Medical Device.
Building a QMS for Your SaMD
Nikita Angane
Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.
More Resources
This blog will explore how the Advanced Manufacturing Technologies Designation Program is shaping the future of ...
In this blog, we explore the significance of drug stability studies, their methodologies, and their role in ...
In this blog, we discuss the significance of SALs for medical devices, their implications for patient safety, and ...