MedTech Summit US

The medical device industry across the US and Europe is in flux. Are you prepared? Join us at MedTech Summit US from November 18 - 20, 2019 in Chicago, IL. We will bring together industry, Notified Body experts and key stakeholders from across the US and from the EU to share the very latest on EU MDR implementation, FDA and software regulations, as well as a pre-conference workshop focused on Medical Device Regulatory Project Management. This dedicated US event will be your opportunity to take away the latest regulatory developments, share insight from industry experts and gather knowledge from leading authorities.

Credits:
This Conference has been approved for a maximum of 13 CPE Credits.

Pre-Conference Workshop Day: November 18th, 2019
• Medical Device Regulatory Project Management

Main Conference: November 19 -20, 2019

Description:
Dig Deep Into Cutting Edge Topics. Ask Challenging Questions. Get to the Heart of the Issues:
Hear the very latest on all things EU MDR:
• Inside track from Notified Bodies on the implementation status, the latest requirements and their advice for industry
• Imperatives for clinical and post market surveillance requirements under the EU MDR and achieve compliance
• Industry case studies and detailed discussion on EU MDR challenges and opportunities.

Navigate FDA initiatives and priorities:
• Assess how global quality requirements are being streamlined as the FDA aligns with ISO 13485
• Understand what steps you should take to ensure 510K device approval
• Leverage Real-World Evidence to fulfill reimbursement requirements

Shine a light on software and digital health:
• Discover FDA regulatory initiatives for software, AI and cyber security
• Benchmark your approach: take ideas from industry peers on gaining regulatory approval for software
• Operationalize security, quality and risk best practice

Additional details will be posted as soon as information is available.