Wound Care Laboratory Testing Requirements: Your Path to Compliance

Operating room with monitor

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In the ever-evolving landscape of wound care, understanding the necessary testing requirements is crucial. The evaluation of a wound dressing depends on the performance of the materials they’re made from, their microarchitecture, and how they’re constructed. To ensure dressings are effective in clinical wound management they must manage the mechanical and biochemical wound environment, effectively absorb exudate, remain in place for the required treatment period, be easily removed, and be acceptable to both patients and health care professionals.

Join us for an informative webinar delving into the critical laboratory testing requirements for wound healing devices. Our speakers will also thoroughly explore FDA and EU regulatory requirements, discuss effective testing strategies, and offer practical insights for navigating unconventional scenarios and novel devices.

Attendees can expect to walk away with a better understanding of:

  • In vitro testing requirements, including the newly updated EN13726 standard
  • Regulatory expectations, with a focus on regional wound care auditors’ requirements
  • The importance of using appropriate test methods to support rapid product development and streamlined routes to regulatory approval

 

Note: As of November 2024, NAMSA is no longer supporting testing related to the EN 13726 standard. If you have any questions on this change or would like to discuss further, please contact us.