8C Healthcare is a first of its kind Medical Device Research Organization in India with combined strengths in Medical Device Strategic Consulting and Product Life Cycle Management. We are a trusted strategic partner to the MedTech community focused towards advancement of medical technology from ‘CONCEPT to CLINICAL USE’ by addressing design and development challenges, fulfilling quality objectives and achieving regulatory milestones with due respect to Cost, Time and Quality.
8C Healthcare provides end-to-end strategic solutions for New Product Development, Iterative Clinical Development, Clinical Research Management, Regulatory Affairs, Quality Management System and Market Access services for global medical device companies in India and abroad.
8C Healthcare was founded in 2010 by a group of self-motivated and like-minded ‘8 Capable’ Biomedical Engineers, who are committed to contribute to human welfare, by fostering medical device innovations that help in the diagnosis or treatment of human ailments and extend the quality of life.
Company’s Keywords:
medical device design, development, physician inventions, product development, medical device clinical research, medical device regulatory affairs, quality management systems fda, iso 13485, risk management, clincial r, d, design for manufacturability, catheter development, design history file, 510 clearance
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