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Regulation, Clinical and Software for Medical Devices


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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota
November 5 - 7, 2024
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota

Decrease Time to Market and Costs by Developing Comprehensive Regulatory Strategies Tailored to US, EU, and UK Regulations

Regulation, Clinical, and Software for Medical Devices 2024: Spotlight on Innovation, PCCP, ISO 13485, Data Sufficiency, EU MDR, RWE, Clinical Evaluations & Investigations, PMS, 510(k)s, eSTARs...

3 Days. Limitless Insights. Stay informed with direct insights from FDA, Industry Leaders, and top Notified Bodies such as TÜV SÜD and GMED North America.


Save up to $500 when you register by Friday, August 16!

Explore the Latest Regulatory Updates for a Strategic Approach to Regulatory Compliance

Navigate the latest US and EU Regulatory Updates for Successful Device Certification

  • Understand the latest landscapes in US, EU and UK for effective regulatory strategies
  • Update your QMS to align with ISO 13485 alongside King & Spalding
  • Ensure clinical data sufficiency and usability

Develop Strategies to Gain and Maintain Compliant throughout the entire Device Lifecycle

  • Shape the future of healthcare by encouraging innovative devices to market
  • Utilize the expertise of our industry panel to incorporate RWE into submissions
  • Hear from FDA on the latest IMDRF

Decrease Costs and Time to Market by Applying Learnings from Key Stakeholders

  • Prepare for flawless submissions with insight on pre-submissions, eSTARs, and 510(k)s
  • Learn from BD to develop methods to decrease clinical inefficiencies
  • Keep compliant post-certification by
Gain Compliance for Medical Device and IVD Software and Artificial Intelligence Globally
  • Navigate the web of US regulatory requirements with help from...
  • Join Siemens-Healthineers and Philips to get to grips with AI/ML requirement landscape
  • Deep dive and apply guidance on the EU AI Act through TUV SUD and Google’s discussion

Immerse in Interactive Industry Learnings to Accelerate Certification

  • Elevate device security through understanding the latest US guidance on Cybersecurity
  • Mitigate risks through a robust risk management strategy, utilising AbbVie’s learnings
  • Improve teams’ efficiencies by incorporating AI/ML in your regulatory working practices

Enhance Your Regulatory Strategies with Cross-Industry Learnings

  • Plan for the future of software and AI/ML regulations with our multi-stakeholder panel
  • Determine PCCP applicability and application strategies from Antrix
  • Build confidence in collecting and using sufficient clinical evidence



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 2024 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 Linda Cole: