October 24 - 25, 2019
JW Marriott Chicago,
Navigate The Evolving Biocompatibility Landscape For Medical Devices
Get To Grips With ISO 10993, The Risk-Based Approach, Chemical Characterization, And Toxicological Risk Assessment, Amidst Global Regulatory Change
ISO 10993 Troubleshooting
Hear from the following ISO/TC 194 experts
- Kelly P. Coleman, Distinguished Toxicologist, Technical Fellow, Bakken Fellow, Medtronic Physiological Research Laboratories
- Anita Sawyer, Biocompatibility Expert (ISO, ASTM, USP)
- Theodore Heise, RAC VP Regulatory and Clinical Services, MED Institute
- Michael F. Wolf, Scientist, Technical Fellow, and Bakken Fellow, Corporate Technology and Innovation Medtronic
Gain answers to the questions keeping you awake at night
- Why is a risk-based approach is being encouraged and what needs to be submitted to authorities?
- Balancing increased requirements with the move from animal testing – when can it be avoided?
- What are the key differences between the MDD and MDR for biocompatibility testing?
- To what extent can biocompatibility requirements in EU, US and APAC can be harmonised?
Practical industry feedback on the topics that matter
- Hear Kent Grove, Principle Biocompatibility Scientist at Abbott share his feedback on their Thrombogenicity Testing and the High Failure Rate study
- Outsourcing chemical characterizations studies: Discuss this challenges and opportunities with Taryn Meade, Senior Biocompatibility Engineer, Fresenius Medical Care – North America
- Gain insight into how ICU Medical are preparing for the impact of the EU MDR with Karen Sargis, Biocompatibility Manager
Pre-Conference Workshop: An Introduction To Biocompatibility
Wednesday, October 23, 2019 | 10am - 4pm
Are you new to the area of biocompatibility, or would you be interested in a refresher? Compliment your main conference pass with our pre-conference workshop - 'An introduction to Biocompatibility'. Providing a broad introduction to the area, including technical aspects and some regulatory areas, this is the perfect opportunity to examine the fundamentals in preparation for the rest of the meeting.
Topics to be addressed include:
- An introduction to biocompatibility
- Biocompatibility vs biological safety
- ISO 10993 structure and content
- The relationship between 10993 and 14971
- Medical device categorization for biological risk assessment
- Chemical characterization vs chemical information
- Physical characterization
- Extractables and leachables testing – when and why?
- Risk assessment using E&L data
- Medical Device Regulation safety requirements
Dr Xiaoling (Sharlene) Dai, Board Certified Toxicologist (DABT), Medtronic
Plus other speakers still to be confirmed.
Meet the speakers
Get To Grips With Medical Device Biocompatibility Testing And Evaluations Best Practice
Take a deep dive on the latest biocompatibility guidance and updates with a particular focus on ISO parts...
MedTech Digital Week:
On 3-6 December 2018 MedTech Digital Week, a 4-day series of topical webcasts and downloadable resources, brought together hundreds of medical device and diagnostics industry professionals for the latest Notified Body and industry insights on the EU Medical Device, IVD Regulations followed by live Q&As.
Watch the webinars on-demand now with representatives from BSI, Abbott, 1MData, Agfa Medical Imaging, PROSYSTEM - an NSF International Company and more.
Interested in sponsoring MedTech Digital Week 2019?
MedTech Digital Week is taking place on 28-31 October 2019. Request details to learn how you can promote your thought leaders at the next digital event.
CONNECT WITH KEY BUYERS AT Biocompatibility for Medical Devices US 2019 in Chicago
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact Linda Cole: LCole@knect365lifesciences.com | +44 (20) 701 76631