Workshop A: Complying with FDA’s Guidance for Cybersecurity to Ensure Secure Product Development & Reduce the Likelihood of a Delayed Product Delivery

Time: 9:00 am
day: Pre Conference Track 1 AM


  • Delving into company experiences with the SPDF guidance document, exploring collaborative approaches and strategic implementation strategies
  • Identifying and isolating pivotal deliverables outlined in the expansive SPDF guidance, simplifying the document for a more digestible and actionable understanding
  • Illuminating gaps within the document to enhance comprehension, fostering a clearer understanding of potential challenges and areas for improvement
  • Aligning the recognized standard IEC 81001- 5-1 with the deliverables in SPDP Appendix 4, elucidating essential submission requirements for seamless compliance and clarity