RAPS Convergence 2024

Join SGS at Booth #1025 during RAPS Convergence 2024, September 17-19, in Long Beach, CA. As Innovator Sponsors of the event, we invite you to explore how our comprehensive solutions can help you navigate the complex regulatory landscape in the medical device industry.

Stop by SGS for:

• Expert Guidance: Learn about CE marking, ISO standards, and global certifications for medical devices, including Software as a Medical Device (SaMD). We offer conformity assessments under the UKCA scheme and MDSAP certification.
• Product Testing: Discuss our reliable and accurate testing solutions, ensuring your medical devices meet international regulatory standards.
• Free Coffee: Start your morning with a complimentary cup of coffee at our booth while learning about the latest industry regulations.

Presentation Highlights:

EU MDR: Technical Documentation – Common Issues

Ibim Tariah, Technical Director

Wednesday 09/18 at 11:00 & Thursday 09/19 at 11:00, Booth #1025

Regardless of experience, organizations preparing technical documentation for the EU’s MDR often face challenges. Join Ibim Tariah as he outlines the most common mistakes and how to avoid them in a two-part session. Followed by an Ask the Expert session.

EU Conformity Assessment of Uncommon Product Configurations

Balazs Bozsik, Technical Director - Medical Audit

Wednesday 09/18 at 3:30 PM, Discover Theater

Join us for a “back-to-the-basics” session that explores the options manufacturers have to structure their multiple-piece products for EU conformity assessment. This session will cover the commercial and regulatory factors that influence product structure, offering a detailed overview of commercialization models along with the benefits and limitations of each.

AI in Medical Devices

Balazs Bozsik, Technical Director - Medical Audit

Thursday 09/19 at 1:00 PM, Booth #1025

A review of the current state and future trends of AI in medical devices. This session will explore the regulatory frameworks and standards that ensure safety and performance, as well as the ethical implications of AI in healthcare. Followed by an Ask the Expert session.

 

  At SGS, we help bring medical devices to market safely and efficiently, ensuring they meet the highest quality and regulatory requirements. We offer CE marking as a Notified Body through our affiliate in Belgium (1639) and in Finland (0598) for SaMD products. SGS is also a UK Approved Body (0120) and an Auditing Organization (AO) for MDSAP certification. With a global network of over 2,700 offices and laboratories, we are your trusted partner in delivering safe, compliant products to market.

Visit us at Booth #1025 to discover how SGS can support your regulatory needs and help you achieve success in the evolving healthcare landscape.

For further information, please contact:

Dominic James
Marketing Assistant
t: +1-862-339-6737