Course objective and outcome
Assessing the biocompatibility of a medical device over its lifecycle can be challenging. However, this is necessary to determine if or how the biocompatibility profile of a device can change overtime. Evaluations include testing strategies that can be difficult to design for example accelerated versus real-time ageing testing. The purpose of this course is to use risk-based approaches to understand how to perform such evaluations and what additional information or testing results can close risks gaps. Additionally, strategies to address failures as well as changes will be outlined.
 
Content
Lifecycle evaluation for single use and reusable medical devices, with a greater focus on single use, will be covered.
 
Cytotoxicity and chemistry testing (extractables and leachables) will be discussed in the frame of lifecycle evaluations to identify when the testing is useful.
 
Case studies, regulatory feedback, stability testing results and lifecycle testing failures will be approached.
 
Finally, a general approach for device changes will be given with a specific focus on understanding the possibility of leveraging previous lifecycle data.
 
Course participants are invited to provide short case studies for discussion and will get feedback from Nelson Labs, please contact Medicoindustrien.
 
Who should attend
Manufacturers who deal with biocompatibility questions related to life cycle evaluations or would like to increase their knowledge on how to deal with changes and failures.
 
Trainers
Elisabet Jamez, Biocompatibility Expert, Nelson Labs
Katleen Peymen, Healthcare Reprocessing Expert, Nelson Labs
Natascha Arnauts, Healthcare Reprocessing and Biocompatibility Expert, Nelson Labs
 
All trainers will be onsite.