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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, MinnesotaNovember 5 - 7, 2024
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota
Fast Track IVD Certification with Access to the Latest US & EU Diagnostic & Software Regulations
Ensure In Vitro Diagnostic Compliance and Strategic Advantage with Direct Insights from the Regulators, Notified Bodies, and Industry Leaders
Three Focused Days Covering Innovation, IVDR, LDTs, eSTARs, 510(k)s, Performance Evaluations, CDx, Post Market Surveillance, PCCP, EU AI Act, ISO 13485 and more...
EARLY-BIRD NOW OPEN FOR 2024!
Save up to $200 when you register by Friday, July 12!
3 DAYS | 2 TOPICS | 1 EVENT
Navigate the latest US and EU Regulatory Updates for Successful IVD Certification
- Develop strategies to gain access to the US, EU and beyond through interactive discussions
- Understand what the LDT update means for you alongside TUV SUD, Thermo Fisher, Antrix and Freenome
- Navigate the complexities of certifying CDx with insight from Regeneron
Develop Strategies to Gain and Maintain Compliant throughout the entire Diagnostic Lifecycle
- Elevate the future of the diagnostic landscape by encouraging innovation in industry
- Utilize learnings from QuidelOrtho and GMED on determining desirable performance data
- Enhance the longevity of your diagnostic through robust PMS plans with help from Freenome
Decrease Costs and Time to Market by Applying Learnings from Key Stakeholders
- Review and apply the latest learnings on ISO 13485 harmonization with Illumnia
- Develop tips and tricks to keep legacy devices on global markets with Thermo Fisher Scientific
- Streamline submission strategies through insights on eSTARs, 510(k)s and EURLs
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
KEY MEDICAL DEVICE STAKEHOLDERS TAKE THE STAGE
Connect With Key Buyers at IVD Regulation and Software 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: LCole@informaconnectls.com
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