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Our certificates and awards

At Custom Medical, we develop products that improve – or even save – people’s lives. It is absolutely essential that these products are safe to use. At the same time, they should be easy to operate and look great. That’s why quality, information security, and outstanding design play a major role in our daily work. On this page, we’ll show you the standards we’re certified to and the awards we’ve won.

ISO 13485 – Quality Management

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It outlines requirements for processes, responsibilities, and documentation related to medical devices and services.

For our work, this means that quality is an integral part of every stage of a project – from planning and implementation to documentation. Study plans, user interfaces, and code must not only be technically sound, but also backed by clear reasoning and consistently documented.

This is precisely where structured quality management helps: with clear processes, unambiguous responsibilities, controlled documents and seamless traceability.

You can download our ISO 13485 certificate here.

ISO 13485 certificate from Custom Medical for quality management in the field of medical devices
ISO 27001 certificate from Custom Medical for information security for sensitive project data

ISO/IEC 27001 – Information Security

ISO/IEC 27001 is the internationally recognized standard for information security management systems. It outlines requirements for the systematic management of information, risks, access, and security measures.

In our projects, we regularly work with confidential product information, technical documents, study data, prototypes or personal information. This data must be protected in a structured manner, processed in a controlled manner and managed in a traceable manner.

Our system supports precisely this: with clear responsibilities, defined access rights, documented processes and risk-based handling of sensitive information.

You can download our ISO / IEC 27001 certificate here.

Design Awards – Award-Winning Design

Our design awards – including the Red Dot Award, the German Design Award, and the UX Design Award – are recognized for their high design quality, user-centric approach, and ability to address complex application contexts.

For medical devices and IVDs in particular, design is much more than just a visual interface. It is about structuring information in an understandable way, making critical states recognizable and guiding users safely through relevant tasks.

We are “Red Dot Winners: User Interface Design” – 2019, 2020, 2021, 2022, 2023, and 2025.
 In addition, our work was nominated for the German Design Award (2022) and received the award (2023 and 2025). In 2020 and 2022, our work was also nominated for the UX Design Award.

Award for interface design and user experience design from Custom Medical
Great Place to Work award for employer quality and cooperation at Custom Medical

Great Place To Work® – Award-Winning Work Culture

We have been recognized as a Great Place To Work® and named a “Best Employer” by kununu. These awards demonstrate that quality is evident not only in the results of our projects, but also in the way we work together.

This is particularly important for projects involving medical devices and IVDs: Great results come from interdisciplinary teams, clear communication, and a culture that fosters accountability, feedback, and continuous learning. A stable and appreciative working environment has a direct impact on project work: Teams work in a more structured way, knowledge remains within the company, coordination becomes more reliable and complex tasks can be handled with the necessary care.

We want to get to know you and your product!

Michaela Kauer-Franz