Ypsomed continuously implements and maintains the highest industry standards throughout design, development and manufacturing. Compliance and quality-oriented thinking is a core component of our corporate philosophy. Our quality management system is certified according ISO 13485 and fulfils worldwide medical device regulations including Medical Device Regulation (EU 2017/745), 21 CFR 820 and MDSAP country regulations.
As a part of its development services, Ypsomed thoroughly documents each stage of the process in a comprehensive Design History File. The documentation includes everything needed for a regulatory submission and can be made available in different submission formats according to customer needs.
At Ypsomed, a state-of-the-art risk management process accompanies every development activity according to ISO 14971. Using best practices, we ensure the lowest possible level of risk through a systematic approach comprising all steps and aspects of device handling, design and manufacturing.
To serve the commercial needs of our customers we manufacture hundreds of millions of parts, components, subassemblies and finished products annually. Regular audits are conducted by our Notified Body, FDA, regulatory authorities and customers. Ypsomed participates in the MDSAP - Medical Device Single Audit Program