Are you active in Medtech and striving to improve the quality of your Technical Documentation? Then our upcoming digital seminar is a must for you! Join us for an exciting and interactive session where we will explore critical aspects of software documentation in medical device applications.
Content of the webinar
In our first session, we will guide you through a successful application process to the Notified Body (NB) and help you optimize your technical documentation for a seamless review. Gain insights to strengthen your documentation and avoid common pitfalls. We will will also explore overall shortcomings in software documentation and present strategies for strategies to overcome these challenges.
It will be an interactive session where together we share experiences and best practices to raise the standard of technical documentation. We will will also address common shortcomings in risk analysis and share concrete methods for implementing effective risk 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. use of medical device 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 tenderingprocess , 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.
