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Navigate the evolving biocompatibility landscape for medical devices

Thank you to everyone who attended Biocompatibility for Medical Devices US 2019! Stay tuned for the 2020 dates and location.

ISO 10993 Troubleshooting

Hear from the following ISO/TC 194 experts
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
Gain answers to the questions keeping you awake at night
  • Why is a risk-based approach 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
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

Led by:
Dr Xiaoling (Sharlene) Dai, Board Certified Toxicologist (DABT), Medtronic
Plus other speakers still to be confirmed.

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...

Evaluation and testing
Selection of tests for interactions with blood
Tests for irritation and skin sensitization
Establishment of allowable limits for leachable substances
Chemical characterization of materials

Webinars On-Demand

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: | +44 (20) 701 76631

Official TraIning Partner | Medical Device Training International (MDTI)

MDTI is a global interactive training partner committed to the personal progression of Medtech professionals. They deliver CPD certified training on a wide range of topics including clinical evaluations, clinical investigations, regulatory affairs, combination products, post-market surveillance and vigilance, In Vitro Diagnostics (IVD), and soft skills. MDTI's courses are delivered in a variety of formats including face-to-face, customised in-house, webinars and online academies.

Embed your knowledge following the conference at their face-to-face training, Understanding Biocompatibility for Medical Devices. 

Conference Sponsors

Official Training Partner

Promotional Participants