ISO 13485: 2016 Certification

Our Commitment to Quality Management and Continuous Improvement

Drugs & Diagnostics for Tropical Diseases is ISO 13485: 2016 Certified at their main headquarters in San Diego. This certification is a prestigious quality management systems standard applicable to organizations that provide medical devices and related services. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). 

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 Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCAS programme.