11.00 – 11.25 uur
- This presentation will present how Software as a Medical Device is defined in FDA and IMDRF guidances; benchmarked to the EU MDR & IVDR. Introduction to BSI’s SaMD team and the pathways and application timelines. Further definition of SaMD will be defined; and key GSPRs will be defined and shared from a notified body’s perspective.
- Another section of the key standards will be explained and the combined processes. What wants the notified body to know in this part?
- Moving on to key guidance, in the MDR; as well the significant changes explained
- A section about technical file presentation; most common reasons for delays in technical documentation reviews
Spreker: Sreenath Sukumaran | BSI Group
Nederlands