American Medical Device Summit-18-19 October 2022

Celegence invites you to join us for the American Medical Device Summit on 18-19 October 2022. Setting the standard on how the industry should connect and exchange ideas, the American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, product development, innovation, technology, and quality/ regulatory aspects of medical devices.

What: Lunch and Learn Roundtable Session on “Process and technology efficiency in post-market surveillance documentation for EU MDR”
When: Tuesday, October 18th at 1.05 PM – 2:05 PM CST
Where: Westin Chicago Lombard, Chicago, USA
How: Register Here
Why: Join this session to understand the impact of EU MDR in the medical device industry and learn how you can increase compliance and produce higher quality CER reports faster, by using dedicated technology.

Join the discussion with over 250 of your industry peers as they explore the challenges and opportunities in medical device innovation, regulatory harmonization, compliance, digital transformation and more. Hear first-hand case studies presented by the executive speaker faculty with extensive experience driving development and process strategy excellence. Walk away with strategic insights for industry, hospital networks and regulatory bodies to collaborate together to streamline processes, optimize development, design, decrease risk, improve speed to market, reduce costs and remain compliant in a rapidly evolving landscape. This October, we encourage you to join the AMD Summit for two days of thought-provoking content and exceptional networking.

Celegence is excited to be a sponsor at the American Medical Device Summit this year in Chicago, USA. Come together with other regulatory affairs professionals to discuss pressing regulatory topics and understand the impact EU MDR and increased harmonization has in the medical device Industry.

This session will be led by Celegence’s Medical Device Regulatory Specialist, 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.

• Demystify the requirements of the EU MDR, and in particular, the ongoing PMS requirements for various reports such as PMCF plans/reports, Clinical Evaluation plans/reports, SSCPs, etc.
• Understand how businesses are approaching the MDR as an opportunity for business transformation.
• Learn to leverage a single source of truth to harmonize data across various documents including your IFU, technical file, and post-marketing documentation.
• See an overview and demo of our cloud-based EU MDR and IVDR compliance platform, CAPTIS™ which can reduce the time it takes to author your clinical documentation by nearly 20%.

Visit us at stand number 11 for complimentary consultations with Celegence’s experts throughout the event.

To learn more, reach out to info@celegence.com, contact us online or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!