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Nutzen Sie die Gelegenheit und melden Sie sich noch heute bei der MedConf in München an. Wir freuen uns auf Ihre Teilnahme am Vortrag.
Live at the MedConf in Munich
19 – 21 October 2021
This year, MedConf will once again provide a stage for experts in device and software development in medical technology. The hybrid event will take place in Munich from 19 to 21 October 2021.
The conference with accompanying exhibition is considered an established and important networking platform in medical technology. Be there – present on site or with an online ticket. The BAYOOMED team is looking forward to exchanging ideas with you.
Also our tip:
What awaits you
Approval of AI-based medical software
As autonomously learning software, artificial intelligence, like humans, is capable of abstract thinking. For the field of medical technology, this opens up a seemingly infinite number of possible applications.
While a weak AI is understood to be an intelligence that is only superior to humans in very specific areas, a superintelligence – equal to humans – can learn and make decisions.
However, in order to be allowed to use artificial intelligence in the development of medical technology products, manufacturers must observe various requirements. Which regulations apply to the European market and what do manufacturers have to consider in order to be able to approve the product in the USA?
In Europe, the requirements of Regulation (EU) 2017/745 for software products apply above all. This is because AI can be considered a sub-discipline of software from a technical perspective. According to Annex I No. 17 of the regulation, software must be designed to ensure repeatability, reliability and performance in accordance with its intended use.
The FDA, on the other hand, distinguishes between artificial intelligence and software-based medical devices. Moreover, only “locked algorithms” with a completed learning phase have been approved in the USA so far.
The lecture will discuss the extent to which the regulatory requirements can be implemented in Europe and the USA. The presentation will also focus on the different approaches of the EU and the FDA.
Miriam Schulze
Director Medical Engineering
Miriam Schulze studied computer science in Dresden and has been working in the field of medical technology for more than 10 years with a focus on risk management and software development.
As Director Medical Engineering at BAYOOMED, she specialises in the standard-compliant development of safety-critical medical software, mobile medical apps and DiGAs according to IEC 62304.
In recent years, Miriam Schulze has been involved as a product owner in numerous projects in the fields of diabetes care, dentistry, IVD, ultrasound, women’s health, etc.
She and her team support numerous MedTech start-ups, pharmaceutical groups and medical technology companies in all phases of the product life cycle: from specification and consulting to development, CE marking and FDA approval.
Alfred Koch
Legal Counsel / Regulatory Affairs
Alfred Koch is Head of Regulatory and Compliance Manager of BAYOOMED, as well as PRRC of BAYOOCARE GmbH and is in charge of all legal and regulatory topics related to EU-VOn 2017/745 and 2017/746 as well as communication with authorities and notified bodies.
With the team of BAYOOMED and BAYOOCARE GmbH, Alfred Koch develops medical applications in the field of diabetes care, addiction therapy, inhalation, ultrasound, etc. as well as applications for the control of medical devices. He is an expert in the field of approval of medical software in the European and American area, as well as for quality management systems according to ISO 13485 and MDSAP.
