November 14 - 16, 2023
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota
Global Medical Device and Biocompatibility Regulatory Updates: Accelerate Market Access & Achieve Compliance
Gain the Latest Insights on International Guidelines and Standards with FDA, Notified Body, Working Groups, and Medical Device Manufacturers
4 Topics across 3 Days: Medical Device Regulatory Project Management Workshop, Biological Evaluation Execution & Authorship Workshop, Global Medical Device Regulation & Implementation, and Biocompatibility for Medical Devices
LAST CHANCE TO SAVE!
Register by October 20 to save up to $200 per pass!
Explore the Latest Regulatory Updates for a Strategic Approach to Regulatory Compliance
Regulatory Project Management
- Early stage development of regulatory strategies
- Establishing a project team
- Establishing and monitoring standards for the entire device lifecycle
- Incorporating clinical evaluations and risk management
- Understanding metrics used for project management and NB performance
- Adapting procedures as the lifecycle develops
Biological Evaluation, Execution & Authorship
- End to end process of biological evaluation plans
- Foundations of biological evaluations
- Test design for BEP
- Determining endpoint tests and critical factors
- Interpreting test results for analysis
- Transitioning data into BER
- Incorporating toxicology
- Lifecycle management of biological evaluation
Global Medical Device Regulation & Implementation
- Identify necessary documentation to expedite access to the US market
- Incorporate best practices for EU MDR compliance with help from industry representatives
- Expand your global reach in the Swiss and UK markets through our multi-stakeholder panel
- Compile technical documentation successfully with help from SGS North America
- Determine clear clinical and post-market surveillance strategies
Biocompatiblity for Medical Devices
- Hear from TÜV SÜD on the latest updates to 10993-1
- Implement best practices to adhering to 10993-17 with help from Abbott, Boston Scientific and Medtronic
- Delve into 10993-18 revisions alongside SGS, Stryker, and Abbott
- Conquer biological evaluation reports
- Justify biocompatibility data under EU MDR
- Address necessities of good laboratory practice
KEY MEDICAL DEVICE STAKEHOLDERS TAKE THE STAGE
MEDTECH SUMMIT US AT A GLANCE
150+
Regulatory Affairs, Quality, Software, Clinical, Post Market Surveillance, Vigilance, Medical Safety Professionals, and Biocompatibility
35+
Expert speakers representing industry, FDA and Notified Bodies
55+
Medical Device, IVD, SaMD, Combination Product and Legal Companies Represented
Connect With Key Buyers at MedTech Summit US 2023 in Minneapolis
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 Roshni Shah: rshah@informaconnectls.com | +44 (0)7776636553
