The MedDev Day keeps the discussion going!
Enrol in the online event to take place in 21st – 24th September 2021!
A 4-day event to discuss ongoing hot topics in the world of Medical Devices (MDs), In-Vitro Diagnostics (IVDs) and Software Medical Devices (SaMD).
The regulations are already tough – and getting tougher. The MDR and the IVDR place more emphasis on a life-cycle approach to safety, backed up by clinical performance data. Both regulations present stringent requirements for Notified Bodies, control and monitoring by competent authorities. Within this context, staying up to date with the latest news and discussions in the global medical device industry is a complex task.
The MedDev Day, organized by LS Academy has reached its third edition, and will once again serve as a central meeting place for the medical technology industry, bringing together lecture forums, interviews, workshops and networking opportunities. The event will be 360-degree overview of the evolving context of medical devices, in-vitro-diagnostics and software.
23. September 2021 at 10:10am until 10:40am, avasis Presentation
Potential of Digital Documentation: Advantages, Disadvantages, and Future Trends
Most medical device companies still work with Word, Excel and PDF files which leads to inefficiency when it comes to creation and maintenance of the technical documentation. This presentation summarizes current challenges with the MDR and in particular for clinical evaluation, PMCF and PMS processes.
Key problem is the reuse of single information across different documents, which results in copy and paste of text elements or references between different documents. Since documents are changed quite often, inconsistencies are inevitable. On the other hand, Notified Bodies often ask for “stand alone” documents including the complete relevant content. In summary: Manufacturers and Notified Bodies have different perspectives on the technical documentation, often resulting in unnecessary discussions and findings that extend the regulatory approval procedure.
Software tools provide a solution for that dilemma, but the implementation is often associated with lots of time, money, and the need for extensive internal resources. Advantages but also disadvantages of software tool implementations are explained and the potential of a unified data model for medical devices highlighted. At the end, an outlook is given on current trends and how creation, maintenance and review of the technical documentation will change in the next 5 years – for medical device manufacturers but also for Notified Bodies.