All over the world!

You know us at MEDICA due to our friendly reception at our booth – with coffee or tea, impulse talks and useful lectures.

Unfortunately, all kinds of beverages are somewhat more difficult this year. Instead neither you nor we have to travel to Düsseldorf to experience worldwide innovations in medical technology, exhibitors and lectures on topics such as health IT or medical administration. MEDICA 2020 will be virtual and our experts are looking forward to exciting discussions with you on the technical documentation of medical devices again this year.

Together with BAYOOMED, Business Unit for Medical Software, we will be representing ourselves with a virtual booth from November 16th to 19th and cordially invite you for a personal exchange and/or one of our lectures at the BAYOOSOFT Academy:

Focus on being productive instead of being busy.

In line with this claim of our Business Unit BAYOOSOFT, this year’s lecture [email protected] will focus on how you can simplify, automate and delegate your daily processes in creating and updating technical documentation. Mark the lecture slots in your calendar today and take part in our event program for free!

Focus on content instead of form - technical documentation with the Risk Manager

daily, 10.00 A.M. at our virtual exhibition stand

Conformity report of the medical electrical device according to IEC EN 60601-1 - How the mountain becomes a molehill

daily, 11.30 A.M. at our virtual exhibition stand

Stop the Sisyphus work - very easy adaptation and versioning of technical documentation

daily, 2.00 P.M. at our virtual exhibition stand

Risks in the software life cycle IEC 62304 - tool-supported traceability

Mon & wed, 3.30 P.M. at our virtual booth

Accelerate the clinical evaluation process with tool support

Tue & Thu, 3.30 P.M. at our virtual booth

The BAYOOSOFT Risk Manager will also be represented by speakers in the official event program this year. In two web sessions we will focus on the following topics:

Risks in the software life cycle IEC 62304 – tool-supported traceability

IEC 62304 defines a framework for MP software life cycles. Mostly traceability matrices are used to prove a compliant development – especially demanding for large systems. We will show you how the use of digital tools can support this process as well as a seamless integration into risk management and thus accelerate the approval process.

Tuesday, November 17, 2020 – 2.00 P.M.

Svenja Winkler

Svenja Winkler

Director Management Solutions

Focus on the essentials and thus increase productivity. - Svenja Winkler has set herself the goal of enabling customers from highly regulated areas and critical infrastructures to do so. She enthusiastically develops and sells a comprehensive product portfolio with her BAYOOSOFT team, covering a wide range of applications in the areas of IT security and medical solutions.

Speed up the clinical evaluation process with tool support

The use of digital tools can help medical device manufacturers to map the process of clinical evaluation according to the Medical Device Directive MDR 2017/745 & MEDDEV 2.71- rev 4 at a central location, to standardize the procedure and to document it in a way that is traceable at any time, thus making this part of quality management faster and more efficient.

Wednesday, 18 November 2020 – 10.00 A.M.

Franziska Weiß

Franziska Weiß

Sales & Business Development Lead

Manual processing of the technical documentation for medical devices and the management of the risk file take up a lot of time and high costs. Franziska Weiß and her Business Development Team have therefore set themselves the goal of supporting, accelerating and ultimately automating processes with high regulatory requirements of medical device manufacturers and in the area of IT security.