Chitransh Groups Pvt. Ltd. is a trusted medical device regulatory consulting agency that supports manufacturers in meeting regulatory requirements and achieving sustainable business growth. We provide complete end-to-end consultancy services for the healthcare industry, covering product design and development, manufacturing facility planning, documentation, and regulatory approvals at both national and international levels. Our expertise includes turnkey solutions, Quality Management System (QMS) implementation, regulatory strategy planning, training programs, licensing, certifications, and approval support. We carefully analyze each client’s requirements and provide customized solutions that ensure compliance with applicable regulatory standards while maintaining cost efficiency and timelines.
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Our experts assist in ISO 13485:2016 Quality Management System implementation, documentation, training, and audit preparation to ensure full compliance with international medical device quality requirements.
We support organizations in implementing ISO 9001:2015 Quality Management Systems to improve operational efficiency, customer satisfaction, and continual improvement.
Complete regulatory support under Indian Medical Device Rules (MDR) 2017, including device classification, licensing, registration, and CDSCO coordination.
We provide end-to-end consulting for the Medical Device Single Audit Program (MDSAP), helping manufacturers comply with regulatory requirements for the USA, Canada, Australia, Brazil, and Japan through a single audit process.
We support medical device manufacturers in achieving compliance with the European Union Medical Device Regulation (EU MDR), including technical documentation, clinical evaluation, risk management, and CE marking.