RAPS-Ontario & SGS Medical Device Symposium

Join SGS at the RAPS-Ontario & SGS Medical Device Symposium

SGS will host the RAPS-Ontario & SGS Medical Device Symposium on November 10, 2026, at the Hilton Meadowvale in Mississauga, Ontario. This full-day conference will bring together medical device and regulatory professionals to explore evolving industry requirements, quality management challenges, and developments in medical device compliance.

Through presentations from SGS specialists and industry professionals, attendees will gain practical insights into MDR/IVDR requirements, MDSAP audits, Software as a Medical Device (SaMD), and artificial intelligence in medical device development.

Explore Medical Device Regulatory and Quality Challenges

The symposium will address key topics affecting medical device manufacturers and regulatory professionals, including:

• MDR and IVDR Compliance: Understand evolving European regulatory requirements, technical documentation expectations, and common non-conformities.
• MDSAP Certification: Explore audit requirements, common pitfalls, and practical considerations for manufacturers preparing for MDSAP assessments.
• Software as a Medical Device and AI: Examine regulatory considerations surrounding software-driven medical technologies and artificial intelligence.
• Medical Device Design and Development: Discuss quality and regulatory considerations throughout the medical device development process.
• Notified Body Expectations: Gain insights into clinical evaluation, regulatory submissions, and conformity assessment requirements.

Hear from SGS Medical Device Specialists

SGS experts Mingxiang Xu and Balazs Bozsik will lead sessions focused on regulatory expectations and practical compliance challenges.

11:00 AM to 12:00 PM | NB Expectations: EU Technical Documentation, Common Non-Conformities and Clinical Evaluation for MDR/IVDR
Presenter: Mingxiang Xu

Explore Notified Body expectations for technical documentation, frequent non-conformities, and clinical evaluation requirements under MDR and IVDR.

1:00 to 2:00 PM | MDSAP: A Practical Guide for Manufacturers
Presenter: Balazs Bozsik

Learn about MDSAP audit preparation, common pitfalls, and considerations involving Medical Device Licences (MDL) and Medical Device Establishment Licences (MDEL).

2:00 to 2:30 PM | Software as a Medical Device and AI
Presenter: Mingxiang Xu

Discuss regulatory considerations for software-based medical devices and the growing role of artificial intelligence in medical technology.

3:00 to 3:30 PM | MDR/IVDR Updates: MDR 2.0 and IVDR 2.0
Presenter: Mingxiang Xu

Review the latest developments in MDR and IVDR and their implications for medical device manufacturers.

The program also includes a Q&A session, discussions on real-world Notified Body experiences, and opportunities to connect with other regulatory 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.

Event Details

• Date: Tuesday, November 10, 2026
• Time: 9:00 AM to 4:20 PM EST
• Location: Hilton Meadowvale, 6750 Mississauga Road, Mississauga, ON L5N 2L3
• Registration: CAD $50
• Additional Benefits: Lunch, networking opportunities, and a $200 training credit for all attendees.

Join SGS at the RAPS-Ontario & SGS Medical Device Symposium to connect with regulatory specialists, gain practical insights into current compliance challenges, and strengthen your approach to medical device quality and market access.

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