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MedTech Summit US
November 14 - 16, 2023
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

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

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