Speaker announcement: Judith de Wilde from Axon Lawyers

Make compliance your success factor – a conference for QA/RA professionals

We are delighted to welcome the next speaker to our Medical Device Product Life Cycle – QA/RA conference on the 26-27th of October in Lund:

Judith de Wilde, Attorney at Law at Axon Lawyers

Judith will deliver two presentations at the conference:

•  Interaction between manufacturers and other economic operators: How to effectively implement PMS in the supply chain
  This session will focus on how manufacturers can ensure meeting their PMS obligations under the MDR by sourcing crucial PMS and PMCF data from the supply chain. Key items to address in a legal agreement with the distributors and other economic operators will be discussed, as well as some other tips and tricks.
• Marketing & Claims: How marketing, clinical evaluation and other MDR processes intertwine
  This session will dive into the interplay between concepts of marketing, clinical evaluation and other MDR processes and how to keep claims consistent between marketing statements and regulatory documentation. The relationship between marketing statements and controlled regulatory documentation in the QMS will be outlined, as well as the impact these concepts have on the dynamic processes of clinical evaluation and PMS/PMCF.

We are looking forward to meeting you in Lund!