Gadgeon is extremely happy and proud to announce that we are now ISO 13485:2016 certified. ISO 13485:2016 is an international quality standard for medical device design and development and is required for registration of medical devices. This accreditation is an important milestone in our journey and will advance our mission of providing high-quality, safe, and consistent services to our clients and end customers.
In summer of 2020, we went through a rigorous audit of our Quality Management System, conducted by BSI, to ascertain that Gadgeon not only has processes in place to meet regulatory requirements specific to the medical devices industry, but also we follow them in our services for designing, developing, building, and operating medical devices.
Gadgeon holds Certificate No: MD 733589 and operates a Quality Management System which complies with all requirements of ISO 13485:2016 for the scope of Design, Development, Testing and Maintenance of Software and Firmware for Respiratory and Vaccine Delivery Medical Devices. This confirms our dedication to delivering best in class solutions for Healthcare through high quality medical products and services.