MEDICA 2020
All over the world!
All over the world!
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.
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.
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.