Safety, quality and reliability
Because that is what really matters
The requirements of precision and accuracy are particularly high in a market where faulty products can have dramatic effects on patients’ health. Ypsomed’s quality system is consistently applied throughout each individual development and manufacturing process.
Our entire development process fully complies with the requirements of the respective cGMP and ISO guidelines. This is ensured by 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.
Our high quality systems standard is continuously challenged by numerous audits every year by customers and regulatory authorities. The FDA audit performed in 2011 resulted in no 483 observations.
A wealth of self-injection device experience
1985 – OptiPen: for Hoechst, one of the world’s first insulin pens.
1989 – KabiPen: for Kabi-Pharmacia the world’s first pen for human growth hormone and for dual-chamber cartridges. 
1999 – OptiSet: for Hoechst Marion Roussel, setting a new benchmark for disposable insulin pens.
2004 – Gonal-f Pen for Serono: first disposable pen for FSH.
2010 – ServoPen: automatic insulin pen with red dot design award, launched as Gansulin Pen by Dongbao in China.
2011 – YpsoMate: the 2-step autoinjector that sets new standards for simplicity and patient feedback.
Intellectual property
Providing protection and managing complex patent landscapes
Innovation alone is no guarantee of success. By safeguarding the intellectual capital in the form of patent protection we provide our customers with the custom solution they require to ensure a clear differentiation from competitors. We hold patent
families with granted patents and patent applications in key countries for pen systems, autoinjector technologies and pen needles.
Besides actively protecting our innovations, we constantly monitor the patent environment and thus possess a comprehensive and in depth knowledge of the specific injection device patent landscape. Based on this broad understanding we ensure that our Custom Products do not infringe third party patents.