Main Conference Sessions

Latest on FDA programs and plans, insightful speakers, roadmaps to accelerate innovation, including:

  • CDRH and ORA: Direction, priorities, and why!

  • FDA harmonizing QSR with ISO 13485: Are you ready?

  • EU: MDR first lessons learned and IVDR latest developments

  • Overdue UK MHRA and Swiss Medic medical device registrations: Are you in compliance?

  • Cybersecurity: Tools for mitigating the growing global risk

  • Biocompatibility: Premarket challenges and successful submission practices

  • Global developments in regulating AI-based devices

  • Connecting the journey of data, metrics, and KPIs to CAPA

  • Investigator insights from the field: Prepare for tomorrow

  • And more!

Conference Workshop

Risk Management: How to Make Validations and Risk Analysis More Robust

Learn effective risk management strategies from an exceptional panel of experts who are rich in industry and FDA experience. You will learn how to take a total lifecycle approach to risk management by walking through a comprehensive case study throughout the day. The facilitators will share industry pain points and successful practices throughout the workshop:

  • Setting the stage:

    • Global regulatory overview

    • 14971:2019 basics and definitions 

  • Planning requirements 

  • Risk management activities for design inputs and outputs

  • Verification and validation activities

  • Strategy for design transfer and postmarket surveillance


“There are always a lot of FDA people on-hand to be really frank and open; to have conversations.”
— Kim Trautman, Medical Device, IVD and Combination Products Expert

MedCon Sponsors 2022

Because of the generosity of our sponsors, we can continue our work to improve the medical device industry. Thank you!

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DISTINGUISHED SponsorS —


In the Medical Device Industry? You Need to Be at Xavier.

At the FDA/Xavier MedCon Conference, global regulators and medical device manufacturers engage to increase speed to market and product quality through innovation. During the conference, you will:

  • Experience paradigm-shifting dialogue leading to practical solutions you can implement today.

  • Learn proactive and predictive methods to protect your products, your business, and your patients.

  • Gain cross-functional insights that foster critical alignment and collaboration across your organization.

This has been one of the best conferences that I have attended.
— FDA/Xavier MedCon Attendee

Register for virtual FDA/Xavier MedCon Conference 2021:


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The balance of FDA and industry is perfect. Plus it’s great to network with such a broad range of attendees.
— FDA/Xavier MedCon Attendee