Software as a Medical Product

Our services

BoHAIMe provides academic start-up projects developing software for the regulated sector with infrastructure and consulting from initial project planning to final implementation to facilitate regulatory compliance for software classified as a medical device under the EU Medical Device Regulation (MDR). To place a medical device on the EU market, manufacturers must operate an appropriate quality management system (QMS) and create and maintain technical documentation for the product.

The BoHAIMe infrastructure provided consists of a certified, EN ISO 13485 compliant QMS for the development and operation of software as a medical device (SaMD), including process documentation templates and integrated IT infrastructure.

The BoHAIMe team supports the start-up with the initial set-up, adaptation and commissioning of the QMS. Through close communication, training and documentation reviews, the project employees are enabled to operate and further improve the established structures independently and to achieve and maintain CE conformity for their SaMD product.

The BoHAIME team provides content in the form of templates and CodeBeamer configurations and supports the start-ups in the individual adaptation and implementation of the processes. The employees of the BoHAIMe team do NOT take on any organizational roles within the start-ups. They only act in an advisory capacity.

All BoHAIMe services offered for start-up projects are free of charge.

Case Study: KiNoH

With the development of the "Children's Emergency Helper" (Kinder-Notfall-Helfer, or KiNoH), a first internal pilot project for the development of software as a medical device using the established and certified quality management system is already being implemented.

KiNoH is a tool that supports medical professionals in the medication process, consisting of prescription, preparation and administration. This tool provides the user with a list of the most common emergency medications with validated dosage guidelines that are required in pediatric emergency scenarios. In addition, KiNoH enables the calculation of medication dosages by entering the weight and age of the individual patient. The user can open the tool from the hospital bed, desktop computer or smartphone.

This safety-critical software application is to be used in the future to support the medication process in the pediatric intensive care and emergency medicine at the UKB, as life-threatening situations in newborns, small children and adolescents require both rapid action and precise dosage of medication.

Product Owner and contact person: Noa Freudenthal