Webinar: Strategies for software documentation and Notified Body application - for MedTech & IVD.

Are you working in Medtech and striving to improve the quality of your Technical Documentation? Then our webinar is a must for you! Join us for an exciting and interactive session where we explore critical aspects of software documentation related to your Notified Body application.

Content of the webinar

In our first of three sessions, we will guide you through a successful Notified Body (NB) application process and help you optimize your technical documentation for a seamless review. You will gain insights to strengthen your documentation and learn how to avoid common pitfalls. We also explore overall gaps in software documentation and present strategies to overcome these challenges.

It will be an interactive session where we will share experiences and best practices to raise the standard of technical documentation. We will also address common gaps in risk analysis and share concrete methods to implement effective risk controls in software development for Medtech. This is a unique opportunity to deepen your knowledge and ensure safe and reliable use of medical software.

Finally, we will highlight the importance of clearly articulating Intended Use and creating a structured documentation that facilitates understanding and review. As well as exploring the importance of cybersecurity within Medtech and gaining practical insights on how to integrate robust safeguards into your software documentation. We will also introduce BSI's services, go through the tendering process, explain how the technical review is conducted, and give a brief overview of Article 120 of the MDR.

Speakers

Magnus Olla, Business Development Manager, Medical Devices - Nordics, BSI.

Magnus joined BSI in 2021, bringing his regulatory & commercial expertise and passion for sales & customer satisfaction to the organization. Magnus has also been involved in several other regulatory areas besides Medical Devices, such as management systems, supply chain, risk management & testing providing - resulting in a broad approach to client interaction & support.

Gustav Hoppe, Senior Expert consultant Medical Device and IVD, Plantvision.

With over 20 years in the medtech industry and experience from both test houses, manufacturing companies and the consulting industry, Gustav has a solid base with expertise in topics such as Regulatory affairs, testing, AI, software, electrical device, cyber security etc.

Information

Date: 2024-02-15
Time: 08:30-
10:00
Location: Digital
Price: Free of charge

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