MedTech Summit US – Speaking Engagement, December 6 – 8, 2022

Celegence is excited to be an ‘Innovator Sponsor’ at this year’s MedTech Summit US, taking place in Chicago from 6 – 8 December. This event brings over 50 expert speakers from the FDA, Notified Bodies, and international industry leaders across 4 focused tracks and more than 55 sessions, including case studies and panels to discuss the evolving global regulatory landscape and share best practices within the MedTech industry.

MedTech Summit US features 4 prominent tracks covering everything needed to help regulatory professionals navigate, accelerate, and maintain regulatory compliance. Take a look at the full MedTech Summit US agenda at a glance to see how you and your team can benefit!

The 4 tracks across 3 days includes:

• Navigate global medical device regulations and optimize implementation
• Stay ahead of the latest regulatory updates for in vitro diagnostics
• Get to grips with the latest requirements on software and AI for medical devices
• Explore the newest revisions to ISO 10993 and biocompatibility best practice

As a hybrid event, delegates will have the option to attend either in-person or virtually. Delegates choosing to attend virtually can attend the conference through a digital experience platform. Access the Digital Experience platform from 1 week prior to the event & on-demand content until 10 days after the conference. Plus, all on-demand recordings will be available for up to 12 months on Streamly platform.

MedTech US 2022: In-Person Pass

MedTech US 2022: Digital Experience Pass

Are you visiting the live event in Chicago? Come talk to us at Booth 2 between 6 – 8 December.

• What: Presentation on ‘FDA plan issuance of new Quality Management System Regulation (QMSR)’
• When: Wednesday, 7 December 2022 10:20 am – 10:50 am
• Where: Hybrid Event
• In-Person: Intercontinental Chicago Magnificent Mile, Chicago, IL
• Digital Experience: Learn more on the Digital Experience page.
• How: Register Here
• Why: Join this session to understand how the FDA rollout of the new Quality Management System Regulation (QMSR) to replace the current Quality System Regulation (QSR) will impact the medical device and in vitro diagnostic industry.This session will be led by Celegence’s RA/QA Subject Matter Expert, Joseph-Richardson Larbi.

• Joseph has 20 years of experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).
• His key expertise includes the preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE marking, and notified body opinion submissions.
• Medical device industry – Joseph has experience in diabetes management devices, nicotine replacement therapy (NRT) devices and pressurized metered dose inhalers (pMDI).
• Joseph has worked for small, medium, and large Biotech companies such as Roche, OBG Pharmaceuticals, and Kind consumer Ltd.

FDA issuance of the new Quality Management System Regulation (QMSR) to industry is meant to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) with an incorporation by reference (IBR) to the 2016 edition of ISO 13485. FDA adoption of the ISO standard comes with some modification to maintain its statutory and regulatory framework. The transition is meant to be seamless as the ISO requirements are substantially similar with the QSR, however, such transition doesn’t go without possible impact to the existing QMS for integration and implementation of the new regulation.

The “FDA plan issuance of new Quality Management System Regulation (QMSR)” presentation will cover:

• FDA reasoning for QMSR rollout.
• Proposed changes.
• Impact to MED DEV/IVD manufacturers.

Visit us at Booth 2 at MedTech Summit US 2022 for complimentary consultations with Celegence’s experts throughout the event. To learn more, reach out to info@celegence.com or contact us online or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!