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2nd Virtual Edition MedtecLIVE & SUMMIT

Join us for exciting presentations!

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Three days of virtual networking and exchange with experts from the medical technology industry are just around the corner: we are looking forward to the second virtual edition of MedtecLIVE & SUMMIT.

The BAYOOMED team will be there live in front of the screens from 20 to 22 April – exhibiting at the virtual trade fair stand and presenting two web sessions.

The organisers promise new highlights for a more beautiful, digital trade fair flair. We look forward to meeting you in person with the matchmaking system and 1:1 video calls.

Are you interested in Digital Health Applications (DiGA)? Join our websession with Miriam Schulze, Director Medical Engineering.

Or be part of the websession with Alfred Koch. He will show you the regulatory perspective of AI in medical devices.

Development of a Digital Health Application (DiGA). Pitfalls, solutions and opportunities

The market with DiGAs is booming. But what should manufacturers keep in mind for secure and rapid development?

What special features need to be taken into account in data privacy? What does the term “interoperability” mean? And what is important when it comes to usability and accessibility?

Miriam Schulze presents pitfalls and clever solutions.

April 20, 13:40 – 14:00 PM

Websession

AI in medical devices – a regulatory perspective

The possible application scenarios for artificial intelligence in medical technology seem endless. But in order to be allowed to use AI 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?

Alfred Koch gives you an overview.

April 20, 14:45 – 15:00 PM

Websession

Miriam Schulze

Director Medical Engineering

Miriam Schulze studied computer science in Dresden and has been active in the field of medical technology for more than 10 years with focus on risk management and software development. As Director Medical Engineering at BAYOOMED, she specializes in the standard-compliant development of safety-critical medical software and mobile medical apps in accordance with IEC 62304.

In recent years, Miriam Schulze has been involved in numerous projects as a product owner in the fields of diabetes care, dentistry, IVD and allergology. She and her team support more than 400 pharmaceutical and medical customers at every stage of the product lifecycle: from specification and consulting to development to CE marking & FDA approval.

Alfred Koch

Legal Counsel / Regulatory Affairs

Alfred Koch is a fully qualified lawyer specialising in medical law, quality management officer and data protection officer for BAYOOMED. After working in international law firms and in the legal department of an international pharmaceutical group, he is now responsible for regulatory issues relating to software as a medical device at BAYOOMED. Alfred Koch is also a coach at the TÜV Rheinland Academy, where he is responsible for quality management topics related to DIN EN ISO 13485.

With the BAYOOMED team, Alfred Koch develops medical applications in the field of diabetes care, dental medicine, pregnancy planning and applications for controlling medical devices. He is an expert in the field of medical software approval in Europe and the USA.

Roundtable

From the idea to a standard-compliant mobile medical app – A field report

The qualification and classification of medical software and mobile medical apps are subject to strict and, above all, complex requirements of the Medical Devices Regulation.

On the basis of the MDCG guidelines, the lecture draws a distinction between definitions and then delves into the topic of medical device classification of software.

In addition to a theoretical part, different types of software and mobile medical apps will be discussed using examples from practice. Furthermore, experiences and approaches from current projects will be shared, which will also shed light on other MDR topics such as clinical evaluation and post-market surveillance activities.

Finally, the question of the continued existence of Class I software beyond the validity of the old Medical Device Directive will be answered. The roundtable will provide an overview of the new developments in the Medical Devices Directive with a focus on software and mobile medical applications.

Different assumptions and interpretations will be discussed, with the audience being guided step by step through the regulation.

Speaker: Miriam Schulze

22. April, 14:00 – 14:30 PM

to the websession