SGS Medical Device Symposium & Workshop with RAPS and OCRA

Join SGS at the Medical Device Symposium & Workshop with RAPS and OCRA

SGS will host the Medical Device Symposium & Workshop with RAPS and OCRA on November 5, 2026, at the Embassy Suites in Santa Ana, California. Join SGS technical specialists and regulatory experts for a day of discussions on FDA requirements, artificial intelligence in medical devices, quality management, and risk assessment.

As regulatory expectations continue to evolve, medical device manufacturers must address new requirements while maintaining product safety, quality, and compliance. This symposium brings together regulatory perspectives and technical expertise to help professionals understand these changes and apply practical approaches to medical device development and regulatory readiness.

Navigate Medical Device Regulation and Risk Management

The symposium will cover key regulatory challenges and provide opportunities to explore:

• FDA ASCA Program: Understand the Accreditation Scheme for Conformity Assessment (ASCA), including the role of testing laboratories and its application during premarket review.
• QMSR and FDA Inspections: Explore implementation of the Quality Management System Regulation (QMSR) and changes to the FDA's inspection model.
• AI in Medical Devices and Diagnostics: Examine regulatory compliance considerations and risks associated with artificial intelligence in medical technologies.
• Risk Planning and ISO 14971: Learn how to approach risk management planning in alignment with ISO 14971 and EU MDR expectations.
• Practical Risk Assessment: Explore risk assessment techniques and benefit-risk evaluation to support medical device safety and regulatory decisions.

Hear from Regulatory Experts and SGS Specialists

The morning program will feature presentations on regulatory developments and emerging technologies:

• 9:10 to 10:00 AM | Standards in Action: FDA's ASCA Program, From Test Lab Through Premarket Review
  Simon Choi, FDA Senior Health Scientist, Conformity Assessment Program
• 10:00 to 10:50 AM | QMSR Implementation & FDA's New Inspection Model
  Janet Pulver, FDA Medical Device Senior Operations Officer/National Expert
• 11:00 AM to 12:00 PM | AI for Medical Devices and Diagnostics: Risks and Compliances
  Balazs Bozsik, Technical Director, Medical Audit/PCPC

Apply Risk Management Principles in an Afternoon Workshop

Following the morning presentations, the program will shift toward practical risk management techniques through two workshop modules led by Julia Schnider, Contract Auditor.

• 12:45 to 1:45 PM | Risk Planning under ISO 14971 & MDR Expectations: Explore approaches to risk planning that address medical device regulatory requirements.
• 2:00 to 3:30 PM | Practical Risk Assessment & Benefit-Risk Evaluation: Examine methods for assessing risks and evaluating benefits in medical device development.

The program will conclude with a speaker Q&A from 3:30 to 4:00 PM, followed by a networking reception from 4:00 to 5:00 PM, providing opportunities to continue discussions and connect with fellow regulatory and medical device professionals.

Supporting Medical Device Quality and Market Access

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.

Join SGS for a day of regulatory insights, practical learning, and discussions focused on strengthening medical device compliance and risk management.

Event Details

• Date: Thursday, November 5, 2026
• Time: 8:30 AM to 5:00 PM
• Location: Embassy Suites, 1325 E. Dyer Road, Santa Ana, CA 92705
• Registration: $75 USD

Register for the SGS Medical Device Symposium & Workshop with RAPS and OCRA to connect with regulatory experts, explore current compliance challenges, and strengthen your approach to medical device risk management.

For further information, please contact:

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