Device QR Services, Inc. was founded by Natalya Koshnitsky after 17 years of Quality Assurance, Quality Systems and Regulatory Affairs experience within the Medical Device Industry.
In her most recent role Natalya Koshnitsky has served as the Director of Quality Systems and Regulatory Affairs where she successfully designed and implemented a global quality management system and obtained an umbrella ISO 13485 certification for three facilities in the US and Central America. She is highly experienced in all areas of quality management system and compliance, including but not limited to CAPA, Internal non-conformance, internal and supplier auditing, supplier control and post market surveillance.
By working with her regulatory partners, Natalya has successfully commercialized medical device products in over 42 countries worldwide, including CE Marking and 510(K) clearance.
Natalya is an authentic leader with a natural ability to connect with various stakeholders of the organization to reach the set objectives and drive business forward.
Having passion for continuous learning, Natalya first moved to Brussels, Belgium, where she lived for four years and achieved her Bachelor of Arts degree in Communication with minor in Business from Vesalius College, graduated with Cum Laude and Best Honor Thesis Award.
Presently, she is a proud resident of one of the Boston areas in Massachusetts. She holds a Master of Science degree in Health Product Regulation from Regis College and the Program for Leadership Development (PLD28) Certificate from Harvard Business School.
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medical devices
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