We implement and maintain the highest industry standards throughout design, development and manufacturing
Our management system fulfils worldwide medical device regulations (incl. 21 CFR 820) and is certified according to ISO 13485:2016 (EU + CAN), ISO 14971:2019 and EU Directive 93/42/EEC or Medical Device Regulation (EU 2017/745), effective on 26 May 2021 (application date). For Ypsomed, compliance with these regulations and standards means not only implementing a quality system but also ensuring that quality-oriented thinking is a core component of our corporate philosophy.
As a part of its development services, Ypsomed thoroughly documents every stage of the process in a comprehensive Design History File. The documentation includes everything needed for a regulatory submission and can be made available directly in CTD or STED format. Alternatively, Ypsomed may issue a MAF.
At Ypsomed, a state-of-the-art risk management process accompanies every development activity. 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.
For the commercial demand of our customers we manufacture every year hundreds of millions of parts, components, subassemblies and finished products that pose many challenges for quality management. This is why specialists in our quality organisation focus on issues relating to the maintenance of the highest possible standards.
Our quality systems are systematically challenged during >50 audits every year by customers, Notified Body’s and regulatory authorities. The FDA audits performed in 2011, 2012, 2014 and August 2016 did not generate any 483 observations. Furthermore, Ypsomed was audited and successfully passed in 2018, 2019, 2020 the MDSAP.