November 18 - 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
Pre-conference Workshop: Medical Device Regulatory Project Management
Keen to master medical device regulatory project management? Gain a solid understanding of the core ingredients needed for successful project management, with insight into future challenges and how to tackle them, and cement this knowledge through case studies and practical exercises.
This one day training course includes:
•A detailed introduction to project management processes and techniques and additional considerations
•Gain an understanding of how to apply regulatory requirements to a project management methodology
•Learn how to effectively manage medical device project cycles
Graeme Tunbridge, mhra
Recently the British Government announced a general election on December 12th. During campaigning periods before an election, communications from government agencies, such as the MHRA, is restricted. Therefore, unfortunately Graeme Tunbridge will be unable to speak at the event in Chicago.
The MedTech Summit US Team apologies for any inconvenience this may cause.
THE MEDTECH SUMMIT US AT A GLANCE
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.
Keeping you informed!
MedTech Report 2019: State Of The Industry
In February 2019, MedTech Summit conducted a survey of medical device and IVD professionals around the world.
Based on 291 responses, this report reveals unique insights into the state of the industry today as we head towards the
key 2020 and 2022 deadlines, the biggest challenges and how industry insiders are tackling them.
Comparing EU and FDA Approaches to Regulating MedTech Software
Medical technology software forms an important part of the medical device industry and recent changes to the regulatory landscape across regions, with respect to the classification and approval process of medical devices, is bound to affect the medical technology industry. While the FDA approval process requires that the device be proved efficacious in comparison to a control device or be substantially equivalent to a predicate device, the EU approval process is based on the intended function of a medical device.
Differences in Clinical Evaluations and Investigations Under the EU
The EU MDR officially replaces the Active Implantable Medical Device Directive and the Medical Device Directive for medical devices. The EU MDR has a key objective of ensuring health and safety of EU citizens by making the medical device regulation more stringent with respect to the requirements for clinical investigation and evaluation. Clinical evaluation for medical devices is necessary to receive a CE mark which is imperative to market medical devices in the European Economic Area.
Digital Health: An Opportunity or a Challenge?
The Journal of Medical Device Regulation has put together a special reprint on digital health, exclusively for MedTech Summit US. The article covers useful topics including:
- AI Capabilities
- Software development trends
- Main medical device technological trends
- The new EU Regulations
- Medical software: an active device?
- MDR scope and transition period
- CJEU case law
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.
CONNECT WITH KEY BUYERS AT MedTech Summit US 2019 in Chicago
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@knect365lifesciences.com | +44 (0) 20 7017 6631