The whole world of medicine: BAYOOCARE @Medica 2021
Live in Düsseldorf and online – 15 to 18 November 2021
The World Forum of Medicine will again take place live on site in Düsseldorf and online. The BAYOOCARE, BAYOOMED and BAYOOSOFT Risk Manager team will be there from 15 to 18 November. In the “IT Systems and IT Solutions” world of experience, you can talk to our experts about medical solutions, the launching of medical devices of all kinds or find out about specialised solutions.
You will find us on site in Hall 12, Booth A31.
Or visit our joint booth with Medical Device Experts at Compamed Hall 14 Booth 14A40. Here you can find out more about the cooperation.
In addition to the personal exchange at our stands, you can also experience us live on stage at the MHIF: Open Mic – or visit our daily lectures at the stand.
Click here for an overview of all the topics and times of the talks at our stand.
MHIF: Open Mic – watch our speakers live on stage
Miriam Schulze
Development of a Digital Health Application (DiGA). Common Pitfalls and how to solve them
18 November, from 2 p.m.
The market with Digital Health Application 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.
Franziska Weiß
Accelerate the process of clinical evaluation with support of digital tools:
18 November, from 2 p.m.
Digital tools support manufacturers to centrally organize the clinical evaluation acc. to MDR 2017/745, MDCG & MEDDEV 2.7/1 rev 4, harmonise procedures and help with traceable documentation. This leads to a more efficient design of this part in quality management. The practical lecture gives an overview of how the process of clinical evaluation can be completely covered and accelerated with tool support.
Our presentations at the booth
15 November
11:00 - 11:30: Simplify technical documentation digitally and comprehensibly
Digital tools can provide you with sustainable support in formative evaluation. In this lecture you will learn how to document the interlocking of risk management and usability in a comprehensible way, how to present the application specifications clearly and transparently and how to record the results of the formative and summative evaluation clearly and in detail.
13:00 - 13:30: From the idea to a standard-compliant mobile medical app - A field report
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.
14:30 - 15:00: How to put an end to redundancies in technical documentation
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%.
17:00 - 17:30: Agility in medical technology
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.
16 November
11:00 - 11:30: Simplify technical documentation digitally and comprehensibly
Digital tools can provide you with sustainable support in formative evaluation. In this lecture you will learn how to document the interlocking of risk management and usability in a comprehensible way, how to present the application specifications clearly and transparently and how to record the results of the formative and summative evaluation clearly and in detail.
13:00 - 13:30: Approval of AI-based medical devices
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.
14:30 - 15:00: How to put an end to redundancies in technical documentation
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%.
17:00 - 17:30: Collaboration under the Medical Device Regulation
17 November
11:00 - 11:30: Simplify technical documentation digitally and comprehensibly
Digital tools can provide you with sustainable support in formative evaluation. In this lecture you will learn how to document the interlocking of risk management and usability in a comprehensible way, how to present the application specifications clearly and transparently and how to record the results of the formative and summative evaluation clearly and in detail.
13:00 - 13:30: 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 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.
14:30 - 15:00: How to put an end to redundancies in technical documentation
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%.
17:00 - 17:30: Agility in medical technology
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.
18 November
11:00 - 11:30: Simplify technical documentation digitally and comprehensibly
Digital tools can provide you with sustainable support in formative evaluation. In this lecture you will learn how to document the interlocking of risk management and usability in a comprehensible way, how to present the application specifications clearly and transparently and how to record the results of the formative and summative evaluation clearly and in detail.
13:00 - 13:30: The Medical Device Law Implementation Act (MPDG): An overview
Maintaining an overview of the Medical Devices Implementation Act (MPDG) is challenging.
We summarise focal points around notification obligations of economic operators, the German Medical Devices Information and Database System (DMIDS) as well as special productions and much more.
14:30 - 15:00: How to put an end to redundancies in technical documentation
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%.
17:00 - 17:30: 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 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.
