Building a QMS for Your SaMD

by | Mar 30, 2020 | Uncategorized

Our Solutions Delivery Specialist, Nikita Angane, explains how to build a strong Quality Management System for your Software as a Medical Device.

Nikita Angane

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.

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Making Quality Systems Work for You

Making Quality Systems Work for You

If your QMS does not have the proper elements, personnel are not appropriately trained, or your firm does not really value the advantages of your QMS, you will likely not reap the same reward.
Customer Needs vs Requirements

Customer Needs vs Requirements

Understanding customer needs and their requirements is critical for an organization to stay in business and are often used interchangeably. Yet, they are not the same.

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