ISO 13485:2016 is an internationally recognized Quality Management System (QMS) standard specifically developed for organizations involved in the design, development, production, installation, and servicing of medical devices. It focuses on regulatory compliance, risk management, and product safety throughout the medical device lifecycle.

Chitransh Groups Pvt. Ltd. provides comprehensive ISO 13485:2016 consulting services to help medical device manufacturers establish, implement, and maintain an effective Quality Management System in compliance with global regulatory requirements.

Our ISO 13485:2016 Services

• ISO 13485 gap analysis and implementation planning
• Quality Management System documentation preparation
• Risk management implementation (ISO 14971)
• Employee training and regulatory awareness programs
• Internal audits and audit readiness support
• Certification and surveillance audit assistance

Benefits of ISO 13485 Certification

• Compliance with global medical device regulations
• Improved product safety and quality consistency
• Enhanced risk management and traceability
• Increased market access and customer confidence
• Strong foundation for regulatory approvals

Why Choose Chitransh Groups?

Our regulatory experts combine practical industry experience with deep knowledge of medical device regulations. We deliver cost-effective, compliant, and implementation-focused ISO 13485 solutions that support long-term regulatory success and business growth for medical device manufacturers.

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