The whole world of medicine: BAYOOSOFT @Medica 2021

How do you get from an idea to an approved medical software or app? What steps are necessary? What methods, processes and tools are needed? And how do you deal with updates?
We will answer these questions about standard-compliant medical software and app development in the lecture.

Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data statuses, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process with over 400 pages of requirements and more than 1,500 tests for applicability.

Using the BAYOOSOFT Risk Manager, we show you how you can accelerate this process systematically and interactively by up to 62%.

IEC 62304 establishes regulatory requirements for the development of medical software. Agile software development seems to contradict the normative requirements. But only at first glance. How can you use the standard in an agile way? Miriam Schulze will show you practical solutions in this lecture.

The possible application scenarios of artificial intelligence in medical technology seem endless. But what has to be taken into account when approving such products?
We give you an overview of the regulatory requirements in the EU and the USA.

Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data statuses, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process with over 400 pages of requirements and more than 1,500 tests for applicability.

Using the BAYOOSOFT Risk Manager, we show you how you can accelerate this process systematically and interactively by up to 62%.

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

We present pitfalls and clever solutions. We look at the specifics of data privacy, “interoperability” and what is important in terms of usability and accessibility.

Edition 3.1 of IEC 60601-1 is a complete revision of the standard for medical electrical equipment. Risk management according to ISO 14971 is thus an essential part of the safety concept of medical devices. In order to avoid redundant and possibly contradictory data statuses, manufacturers of medical electrical systems are faced with the challenge of introducing an efficient and safe process with over 400 pages of requirements and more than 1,500 tests for applicability.

Using the BAYOOSOFT Risk Manager, we show you how you can accelerate this process systematically and interactively by up to 62%.

IEC 62304 establishes regulatory requirements for the development of medical software. Agile software development seems to contradict the normative requirements. But only at first glance. How can you use the standard in an agile way? Miriam Schulze will show you practical solutions in this lecture.