SGS Lake Nona MedTech Regulatory Innovation Symposium

Join SGS at the Lake Nona MedTech Regulatory Innovation Symposium

SGS is hosting the Lake Nona MedTech Regulatory Innovation Symposium on October 29, 2026, at the GuideWell Innovation Center in Orlando, Florida. Join SGS specialists, regulatory professionals, innovators, and healthcare leaders for a one-day conference focused on medical device innovation, regulatory compliance, patient safety, and the challenges shaping the future of medical technology.

As medical technologies evolve, manufacturers must balance innovation with regulatory expectations for safety, quality, and performance. This symposium brings together industry expertise and regulatory perspectives to explore practical approaches to clinical evidence, medical device submissions, artificial intelligence, cybersecurity, and quality management.

Explore Medical Device Innovation and Regulatory Compliance

Throughout the symposium, attendees will gain insights into topics affecting medical device development and market readiness, including:

• Regulatory Changes and Market Readiness: Explore upcoming regulatory developments, EUDAMED readiness, and considerations for medical device compliance.
• Clinical Evidence and Regulatory Confidence: Understand the role of clinical evidence in supporting medical device innovation and regulatory submissions.
• AI, Cybersecurity, and SaMD: Examine the regulatory considerations surrounding artificial intelligence, cybersecurity, and Software as a Medical Device (SaMD).
• Quality Management and FDA Expectations: Learn about the FDA's Quality Management System Regulation (QMSR), inspection priorities, and conformity assessment.
• Testing and Regulatory Submissions: Explore how mechanical testing and supporting evidence contribute to medical device submissions.
• Digital Transformation and Risk Management: Discuss the evolving role of digital technologies and artificial intelligence in regulatory affairs and medical device risk management.

Hear from SGS Specialists

SGS experts will contribute to the day's discussions through two presentations:

• 10:15 to 10:55 AM | Turning Medical Device Innovation into Regulatory Confidence: Clinical Evidence
  Ming Xu, SGS
  Explore the importance of clinical evidence in supporting medical device innovation and building regulatory confidence.
• 11:45 AM to 12:15 PM | AI, Cybersecurity & Software as a Medical Device (SaMD)
  Balazs Bozsik, SGS
  Examine the intersection of artificial intelligence, cybersecurity, and software-driven medical technologies, including their regulatory considerations.

SGS will also participate in the Executive Leadership Panel: The Future of MedTech Innovation, from 4:20 to 5:00 PM, bringing additional perspectives to the discussion on the industry's direction.

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.

Connect with the MedTech Community

Beyond the presentations, the symposium offers opportunities to exchange ideas and build professional connections through a networking breakfast, scheduled breaks, lunch, and a Networking Reception & Innovation Lounge from 5:10 to 7:00 PM.

Join SGS for a day of discussions focused on the regulatory and technical challenges facing medical device manufacturers and the opportunities ahead for medical technology.

Event Details

• Date: Thursday, October 29, 2026
• Location: GuideWell Innovation Center, 6555 Sanger Road, Orlando, FL 32827
• Registration: $199 USD

Register to attend the SGS Lake Nona MedTech Regulatory Innovation Symposium and connect with professionals working to advance medical device innovation, quality, and regulatory compliance.

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