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IZiel Healthcare
↗Pune, India
IZiel Healthcare is an engineering and regulatory services provider that specializes in supporting global medical device manufacturers. The company offers end-to-end product development, including design, process validation, software validation, and quality management system (QMS) consulting to ensure compliance with USFDA, CE, and ISO 13485 standards.
Operating with a hybrid model across India and the USA, IZiel assists clients ranging from startups to large multinational corporations in navigating the stringent regulatory landscape of the medical device industry. Their services encompass risk management, cybersecurity, and remediation of regulatory observations, aiming to accelerate time-to-market for medical devices.
CLASSIFICATION
Company Type:CRO
Therapeutic Areas:-
Industry:Medical Devices
Sub-Industry:Engineering & Regulatory Consulting
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$10M
Founded:2007
Ownership:private
Status:operating
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CORPORATE STRUCTURE
Parent Company:IZiel Group
Key Partnerships:Various US-based partner organizations for regulatory and remediation projects
COMPETITION
Position:Niche Player
Competitors:Greenlight Guru
LEADERSHIP
Key Executives:
Ankur Naik - Managing Director
Sarvesh Mutha - Managing Director
Asavari Dandekar - Director
LINKS
Website:izielhealthcare.com
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