The program is almost complete, below you will find sessions and speakers with preliminary titles for some of the topics, giving a hint of what is coming during the two conference days. Q/A, a poster session and panel discussions will be included. 

Training Day: September 26, 9 am – 5 pm

A training day in the spirit of Limulus Bio, among other things, the EU MDR and Toxicological Risk Assessments. Updates will follow.

Conference Day 1:  September 27, 8 am – 5 pm

Registration 8-9 am

  • Welcome to our world – the current state of ISO 10993
    Setting the scene – Challenges that we currently face in medical device toxicology, Ron Brown  (Risk Science Consortium, US)
    Keynote speaker: New standards and ongoing development – what happened since BM2022?, Jeremy Tinkler  (Chair ISO TC 194, ICON, UK)

  • The role of Chemistry in evaluation of Medical Devices
    Chemistry issues, Eric Sussman (MCRA, US)

  • Aspects of extractions – fluid and gases
    Use of simulating solvents, Ted Heise (Convenor 10993-18, MED Institute, US)
    Interactions/extractions, how parameters affect the outcome, Jianwei Li (Chemical Characterization Solutions, US)

  • Toxicological Risk Assessment
    Overview of Changes to ISO 10993-17, Sherry Parker  (SParker Consulting, US)

    Use of simulated-use extractable studies to refine exposure estimation for toxicology risk assessment, Kimberly Ehman (WuXi AppTec, US)

    • Exaggerated and exhaustive extractables often lead to overly conservative TRAs, with unfavorable conclusions around potential risk
    • When MOS values are  < 1, simulated-use studies provide a profile of release kinetics that allow for refinement of exposure assumptions in the TRA
    • Three simulated-use examples will be presented that include different types of patient exposure: mucosal contact, gas pathway, and a circulating-blood implant  
    • Regulatory feedback on each approach will be discussed

      Case Study, Joel Cohen (Gradient, US)


  • Panel discussion
    The need for exhaustive extraction – pros and cons

Conference Dinner: September 27

Conference Day 2:  September 28, 8.30 am – 4 pm

Emerging approaches for the safety assessment of medical devices

  • Introduction to day two, Philip Clay(Chorley consulting, UK)


  • The case of implantation – When and why are implantation studies really relevant?
    When and why are implantation studies really relevant?, Lars Magnus Bjursten (Convenor ISO 18562, Sen Prof Bioimplant Res, SE)

  • New risk assessment approaches to evaluate skin sensitization

  • Safety assessment addressing inhalation
    ISO 18562 – Evaluation, testing and new approaches, Lina Burman (Limulus Bio, SE)
    In vitro methods to assess inhalation toxicity, Amy Clippinger (PETA Science Consortium International, US)

  • Closing plenary
    Reflection of the conference – where are we going, Arthur Brandwood (Project Leader – revision of ISO 10993-1, AU)

  • Panel discussion

 * The program is in draft form and Limulus Bio reserves the right to make adjustments