November 19 - 20, 2019
Renaissance Chicago Downtown Hotel,
EU MDR implementation, US FDA updates and Software regulations
Bringing together industry, Notified Body experts and FDA insight, to share the very latest on EU MDR implementation, FDA policy and digital health
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
Meet our thought leaders
WHO WILL YOU BE RUBBING SHOULDERS WITH?
EARN YOUR CPE CREDITS!
To ensure that you walk away from this conference with all the tools you need to succeed, MedTech Summit US 2019 offers Continuing Professional Education (CPE) Credits to attendees.
Following the conclusion of the conference, all attendees will be eligible to earn up to a total of 11 credits for the 2 days of attendance*.
*Continuing Professional Credits (CPE) will be provided in accordance with the National Association of State Boards of Accountancy (NASBA). State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. All credits will be provided following the conclusion of the conference.
MedTech Digital Week
MedTech Digital Week is taking place on October 28-31, 2019.
Request details today and learn how you can promote your thought leaders at the next digital event, a 4-day series of topical webcasts and downloadable resources on the following topics:
- Monday - EU MDR: Latest updates and practical experiences
- Tuesday - Clinical Evaluations: The EU MDR and your clinical strategies
- Wednesday - Post Market Surveillance and Vigilance: Practically implementing the EU MDR PMS requirements
- Thursday - EU IVDR: Get ready for the move to the IVDR
Medical Device Training International | MDTI
MDTI is the global leader in training for MedTech professionals and the official training partner of MedTech Summit. We deliver CPD certified training on a wide range of topics including clinical evaluations, clinical investigations, regulatory affairs, combination products, PMS and vigilance and In Vitro Diagnostics (IVD). Our courses are developed by our global network of experts and delivered via classroom courses, online academies and customised training programmes.