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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


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



Regulatory Affairs, Quality, Software, Clinical, Post Market Surveillance, Vigilance, Medical Safety Professionals, and Biocompatibility


Expert speakers representing industry, FDA and Notified Bodies


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: | +44 (0)7776636553