Implementation strategies and guidance across all aspects of biocompatibility testing and evaluations
Latest ISO 10993 revisions and new FDA guidance updates for compliant biocompatibility strategies
- How can the TTC approach be practically applied to everyday work?
- The chemical characterisation risk assessment approach - how are companies applying this?
- French authorities' objections against EN ISO 10993-7 and concerns for EO residues in devices for newborn and paediatric use - what are the implications?
- ISO/TR 10993-22 and expectations for nanomaterials - what is the latest status?
Direct access to the FDA, Notified Body and industry representatives
- TÜV SÜD provide practical advice on biocompatibility submissions
- Understand the power of material characterisation for biological evaluation of medical device wearables - insight from UL MDT
- Direct updates from ISO/TC 194 including an overview of DIS 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications (parts 1-4)
- Geistlich Pharma AG provide an update on the key impacts of the European Medical Device Regulations (MDR) on biocompatibility testing
Networking and knowledge exchange with your peers
- Get your questions answered with our interactive sessions:
- Extended Evening Session: Country-Specific Global Requirements Round Tables including Japan, China and South Korea
Notified Bodies Problem Solving Session: Practical advice on biocompatibility submissions
Flash case studies on applying the chemical characterisation risk assessment approach
Interactive Panel Discussion on sharing experiences with the TTC approach
- Also join a shared plenary session and hear from a Patient Inventor & Advocate with our co-located meeting: Drug Device Combination Products - visit the website
Bringing together biocompatibility experts for focused networking
Meet, benchmark and be inspired by the industry's leading experts
Meet with the biocompatibility community for improved knowledge, networking and experience exchange
Who Can You Expect to Meet?
Senior Director/Director/Head of/Manager/Associate
- QA / Quality Assurance
- RA / Regulatory Affairs
- R&D / R&D Engineer
- Materials Specialist / Material Characterization / Material Expert
- Product Safety
Evening Drinks Reception
- Grab a drink and join your peers for an evening of socialising.
2 Conferences in 1 Location
- The meeting will be co-located with our Drug Device Combination Products conference, providing enhanced networking opportunities and a platform for cross-functional discussion.
Meet our 25+ experts and thought leaders
The meeting place for the biocompatibility industry
Reduced Rate Accommodation
Informa does not have a 3rd party hotel booking agency representing this event aside from the below links. If you are contacted to book accommodation by any agency, this is not recommended, as they are unknown to Informa and the hotel.
To book reduced rate accommodation at the Sofitel Berlin Kurfustendamm please contact the hotel directly on tel: +49 30 800 99925 or email H9387-RE1@sofitel.com.
Please click here to book alternative accommodation options.
Medical Device Training International | MDTI
MDTI is a global interactive training partner committed to the personal progression of Medtech professionals. We deliver CPD certified training on a wide range of topics including clinical evaluations, clinical investigations, regulatory affairs, combination products, PMS and vigilance, In Vitro Diagnostics (IVD)and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.