Featured Speakers 2022
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
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
Risk management activities for design inputs and outputs
Verification and validation activities
Strategy for design transfer and postmarket surveillance
MedCon Sponsors 2022
Because of the generosity of our sponsors, we can continue our work to improve the medical device industry. Thank you!
Premium SponsorS —
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.