• FDA expectations
  • Adhering to expectations – pain points
• Link to Biocompatibility testing
• Successful execution example

• Expectations of data for varying device classes
  • Legacy devices
• Data assessments
  • Preparing for Notified Body audits
  • Common misconceptions and how to overcome
• Case study: successful data justification

• To detail a weight of evidence framework for assessing medical device biocompatibility.
• To discuss the applicability of the data inputs within the weight of evidence framework.
• To explain how to reach a patient safety conclusion within the weight of evidence approach.

Please contact: Roshni Shah - roshni.shah@informa.com Or Call + +44 (0)20 8052 0405 if you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Background to biocompatibility evaluation of breathing gas pathways
• Understanding the key changes to ISO 18562
• Impact on industry

• Methods of in vitro testing
• Global status of in vitro acceptance
  • Which countries are accepting? Which are more reluctant?
• Future of in vitro
  • Global plans for wider acceptance
  • Impact on industry

• ISO 11607-1 and –2 contribution to establishing shelf life
• Strategy development for addressing shelf life of high-risk products
  • Key touch points and common mistakes
• Harvesting and utilizing shelf-life data
• Defending shelf life in terms of biocompatibility testing

• Expectations of Regulatory Authorities and Notified Bodies of GLPs
  • Are they always mandatory?
• Effective documentation of GLP
• Verification of GLP status of a test report

Please contact: Roshni Shah - roshni.shah@informa.com Or Call + +44 (0)20 8052 0405 if you are interested in participating as a speaker, panelist, moderator or hosting a webinar

Despite advancements in materials science, the proportion of medical device recalls attributed to the materials of construction has remained unchanged over the last two decades. This seemly static statistic does not implicate innovation in the space but speaks to the success of implanted device therapies. Patients are being diagnosed earlier and are living longer. At the same time, procedures are becoming less invasive, driving miniaturization. Both trends are pushing materials to their limits, threatening to constrain future longevity expansion and miniaturization without the introduction of new materials. Evaluating the biostability of a new material over the decade or more in vivo exposure timeframes that modern-day implants require, raises important questions about the methods used to assess biostability. Historically, end of life performance was evaluated by implanting devices and/or the materials that comprise those devices in an appropriate pre-clinical model and extrapolating the performance to the expected end-of-life. However, the comparatively short implant duration, the high variation and the low statistical power of the pre-clinical assessment introduces significant error when extrapolating performance to modern day implant times. Furthermore, the recent European Union Medical Device Regulations (EU MDR) are demanding more specificity in the evaluation of end-of-life performance, with eleven references to the assessment but omitting detailed methods for evaluation. In this talk, I will review our scientific advancements in predictive accelerated testing for biostability, where the accelerated models have been validated with up to twenty years of human implant data.

• Reconnecting the regulatory expectations on lifecycle management
  • Link to change vs risk
• Mitigating lifecycle management changes
  • Supply chain, materials, manufacturing
• Best practices for effective long-term lifecycle management

Have all of your burning questions answered by experts from the previous 2 days on all things Biocompatibility.