ISO 13485 Certification in Mumbai

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO 13485 is a stand-alone Quality Management Systems (QMS) standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of ISO 13485 Medical Devices?
• Increase access to world's market with ISO 13485 certification.
• Improved process in medical device manufacturing, packaging & supply.
• Increase efficiency, cut costs and monitor supply chain performance.
• Demonstrates that your products are safer and effective medical devices.
• Meeting regulatory / statutory requirements and customer expectations.

EN ISO 13485 is the international standard for quality management systems for medical devices. We examine your quality management practices for medical devices, focusing on design and development, production, customer service, and assembly. Benefit from the positive effects of a quality management system: lean processes, efficient work flows, and international recognition. CDG Certification Limited is a pioneer ISO 13485 Certification Company in Mumbai. Contact us immediately for ISO 13485 (MD-QMS) Certification.

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