Each project at Ypsomed is unique. By flexibly applying a standardised development process, we are able to focus on the real task at hand – the development of successful solutions for our customers. Our standard staged development process consists of the following phases for a complete project: Evaluation and definition of customer requirements, concept finding and selection, design realisation and design freeze, industrial implementation and validation. Based on the scope of the activities to be covered, each project is individually managed through the relevant phases. This process complies with the requirements of the respective cGMP and ISO guidelines at all times (FDA 21 CFR 820. 30 and ISO 13485:2003).

It goes without saying that this process is conducted using design control systems such as stringent cross-functional reviews at key milestones, comprehensive risk assessment procedures throughout the entire project and thorough design verification and validation procedures. Ypsomed possesses specific expertise and uses the latest tools to reduce the number of development loops during the process.

Design controls

Ypsomed applies design controls according to the US FDA. They constitute a system of checks and balances to ensure that a systematic assessment of the design remains an integral part of development. The approach comprises the systematic and step-wise definition of requirements, followed by the verification of design output against the requirements. Regular design reviews form  an essential part of the procedure, whereas design validation confirms that the final device fulfils the user needs.

All our processes are subject to the medical device guidelines and are certified according to ISO 13485:2003. For Ypsomed, compliance with this standard means not only implementing a qualitysystem 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.

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.

As a large-scale manufacturer of injection devices, Ypsomed is able to offer its customers expert advice in defining the manufacturing and scale-up strategy. Such a strategy has to consider the required device quantities at different stages of the programme and is likely to involve several steps.

Our experience covers the whole spectrum: low volume manufacturing using manual processes, semiautomated and hybrid-automated processes, and high volume manufacturing using fully automated high-speed processes.