SGS RAPS Symposium: Practical EU MDR, UKCA, and FDA Risk Management & Labeling Workshop 2026

Meet SGS at the SGS RAPS Symposium: Practical EU MDR, UKCA, and FDA Risk Management & Labeling Workshop 2026

SGS is partnering with RAPS for the SGS RAPS Symposium: Practical EU MDR, UKCA, and FDA Risk Management & Labeling Workshop 2026, taking place on July 22, 2026, in Minnetonka, Minnesota. Join SGS experts for a full-day, interactive workshop focused on practical approaches to medical device risk management, labeling, and regulatory compliance.

Designed for regulatory, quality, clinical, and R&D professionals, the workshop provides practical, Notified Body focused perspectives on building, maintaining, and reviewing EU MDR, UKCA, and FDA QMSR compliant risk management documentation and related IFU and labeling outputs.

What You'll Learn

• Risk Management Planning: Build ISO 14971 compliant risk management plans that support EU MDR and UKCA lifecycle expectations.
• Risk Assessment: Develop hazard to harm logic, evaluate benefit-risk, assess risk controls, and strengthen traceability throughout the risk management process.
• IFU and Labeling: Translate risk controls into compliant warnings, precautions, contraindications, training requirements, and residual risk disclosures aligned with GSPR 23.
• Notified Body Review Expectations: Identify common deficiencies and learn practical self-review techniques using Notified Body style assessment approaches.
• FDA QMSR: Understand FDA expectations for risk management, systemic evaluation areas, and broader QMSR requirements.
• Hands-On Workshops: Apply concepts through live review exercises, practical examples, and simulated Notified Body assessments.

Medical Device Expertise from SGS

At SGS, we help bring medical devices to market safely and efficiently. As a full-solution provider, we help medical device clients ensure their products are of highest and consistent quality, while meeting the regulatory requirements for their intended purpose. We offer medical device CE marking as a Notified Body through our affiliate in Belgium (1639) for clients needing certification specifically for Software as a Medical Device (SaMD) products. SGS is a UK Approved Body (0120) able to provide conformity assessments under the UKCA scheme for Great Britain and is an Auditing Organization (AO) for MDSAP certification. SGS provides training, assessment, testing and certification through our network of more than 2,700 offices and laboratories across the world.

The workshop will be led by SGS medical device experts, including Mingxiang Xu, Daniel Fisher, and Leo Pidone, and concludes with a networking reception where attendees can continue discussions with the SGS team.

For further information, please contact:

Dominic James
Marketing Assistant
t: +1-201-508-3000