It should come as no surprise, that success in medical devices means overcoming compliance challenges. The business case for quality compliance is undeniable - quality affects every stakeholder in the medical value chain. Quality is a central concern from product design through manufacturing and marketing.
DSI is leading the pack with an ISO 13485:2016 and CE - Full Quality Assurance System certification for medical devices, issued by MDC medical devices registration Gmbh, Germany. This combination of the highest level of Quality Management System certification and top-tier Notified Body is among the most difficult and globally recognized certifications to obtain and maintain.
We mantain our quality management system through documented procedures, qualification of personnel, validation of processes and an emphasis on customer satisfaction and feedback. DSI continues its quality management system preservation with monthly quality and data analysis meetings, bi-annual internal audits, and an annual external audit from an ISO certification body.
DSI has also successfully established the FDA Medical Devices Registration and obtain the FDA 510(k) approval for certain implant products. The ISO 13485:2016 requirements exceed that of the FDA’s requirements for medical device manufacturers. This gives the DSI customers an added confidence in the quality, authenticity and performance expectations of the products we provide to our medical professionals.