ISO 13485 is the International standard for Quality Management System For Medical Devices.ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. This differs from ISO 9001:2000 which focuses on customer satisfaction and continual improvement.
Why do I need it?
ISO 13485 standard provides a way to reduce variation. Reducing variation can provide financial benefits for the company, such as reduced scrap and general process efficiencies.
ISO 13485 purchasing requirements cover purchasing from qualified suppliers, according to pre-established specifications, and assuring that purchased product meets those specifications.
Because we keep the entire process hassle-free, ISO 13485 Certification can take just 7 - 30 days to complete based on your company's size. In fact, our 'Keep it simple' approach means we can:
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