7th Edition US Medical Device Human Factors and Usability Engineering Conference

Meet SGS at the 7th Edition US Medical Device Human Factors and Usability Engineering Conference

SGS will participate in the 7th Edition US Medical Device Human Factors and Usability Engineering Conference, October 20 to 22, 2026, at the Embassy Suites by Hilton Boston at Logan Airport in Boston, Massachusetts. Visit us at Stand 6 to discuss human factors, usability engineering, risk management, regulatory compliance, and medical device certification.

As regulatory expectations for medical device usability evolve, manufacturers must demonstrate how critical task identification, risk management, and validation support product safety. SGS helps manufacturers navigate these requirements and strengthen the evidence supporting regulatory submissions.

Strengthen Medical Device Compliance with SGS

Connect with our specialists to explore:

• Human Factors and Usability: Address critical task identification, usability validation, and documentation for regulatory review.
• Risk Management: Connect use-related risk analysis, risk controls, and validation evidence to support regulatory submissions.
• EU MDR and IVDR Compliance: Discuss conformity assessments, technical documentation, and certification requirements.
• Global Market Access: Explore CE marking, UKCA, MDSAP certification, and ISO 13485 quality management requirements.
• Medical Device Testing: Learn about testing services supporting product safety, quality, and regulatory compliance.

Hear from SGS Specialists

SGS experts Mingxiang Xu, Technical Director, and Leo Pidone, Senior Lead Medical Device Auditor / Technical Reviewer and Certificate Decision Maker, will share insights into human factors validation and regulatory expectations.

October 20 | 10:00 AM
Workshop: Building Defensible Critical Task Frameworks for Regulatory Scrutiny
Presenters: Mingxiang Xu and Leo Pidone

Explore critical task classification, connections to risk controls and validation, and approaches to addressing regulatory scrutiny and submission deficiencies.

October 21 | 12:00 PM
Presentation: How to Write High-Quality Human Factors Validation Reports for Submission
Presenter: Mingxiang Xu

Learn how to structure validation reports, document critical tasks, connect use-related risk analysis (URRA) with safety conclusions, and address common regulatory review concerns.

October 21 | 2:15 PM
Panel: Is Human Factors Becoming the Primary Regulatory Gatekeeper?
Panelist: Mingxiang Xu

Discuss increasing regulatory scrutiny, validation expectations, risk integration, and the balance between innovation and regulatory readiness.

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.

Visit Stand 6 to meet SGS specialists, discuss your human factors and regulatory challenges, and explore solutions supporting medical device safety, compliance, and market access.

For further information, please contact:

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