The Challenge iThera is a technology leader in clinical and preclinical optoacoustic imaging. Combining highly optoacoustic imaging with ultrasound, they achieve unique image quality and resolution. The latest generation of devices was also to be marketed in the USA. In particular for the software, this raised the question: what could be adopted and what needed to be redeveloped? Zühlke was tasked with analysing whether the quality of the software for the research system was sufficient to meet FDA requirements and enable it to obtain approval for the US market. The Solution Zühlke carried out an initial assessment to examine key questions relating to the software architecture, code base, documentation and approval. Short workshops were held to examine key topics. These included fitness of the architecture, the quality assurance process, approval strategy and an evaluation of the planned extension. These were followed by targeted consultancy work from Zühlke on cybersecurity and software architecture for FDA approval. The Results Zühlke’s goal-focused, needs-oriented consultancy avoided a highly complex redevelopment process and reduced development costs. Zühlke identified an alternative approach involving carefully targeted actions to address points of vulnerability, for example closer coordination with the notified body/FDA, improvements to the documentation and a lightweight refactoring of the codebase to improve demarcation between different software items. ' Zühlke was quick to get to grips with our problem and developed a number of alternative courses of action in just weeks. Most importantly, the assistance they gave us with our documentation helped get our de novo FDA submission on track without needing to rewrite the software from scratch. ' Dr. Patrick Leisching CTO, iThera Contact person for Germany Thorsten Knauf Director Business Development Thorsten Knauf is a Senior Manager who has been working for almost 30 years in the international consulting services industry. He has gained broad experiences from several mission critical and innovative IT and engineering projects across industries. As a partner for business innovation with an agile mind set his current focus is primarily on digital business models, products and services. Contact thorsten.knauf@zuehlke.com +49 40 55 89 17 12 32 Your message to us You must have JavaScript enabled to use this form. First Name Surname Email Phone Message Send message Leave this field blank Your message to us Thank you for your message. Our work Medical Device and Healthcare Singapore-ETH Centre LvL Up: A smartphone-based digital lifestyle coach Learn more Medical Device and Healthcare Telemonitoring for high-risk covid patients Learn more Medical Device and Healthcare Empowering Indonesia's healthcare ecosystem with a personalised healthcare app Learn more Go to client success stories Do Work That Matters – From Ideation to Implementation and Beyond Apply now
' Zühlke was quick to get to grips with our problem and developed a number of alternative courses of action in just weeks. Most importantly, the assistance they gave us with our documentation helped get our de novo FDA submission on track without needing to rewrite the software from scratch. ' Dr. Patrick Leisching CTO, iThera