The Bioengineering Department at KFUPM, in collaboration with IRC-Biosystems and Machines, successfully conducted the Medical Devices Regulations Workshop on Wednesday, January 22, 2025. The workshop was a resounding success, attracting students, researchers, and professionals eager to learn about the latest developments in medical device regulations.

Expert-Led Sessions:

The workshop featured distinguished experts from the Saudi Food and Drug Authority (SFDA - هيئة الغذاء والدواء):

• Mohammed Basim Alnassar – Senior Product Registration Support Expert
• Rinad Al-Haqbani – Senior Scientific Evaluation Specialist
• Nadia M. Alghamdi – Senior Scientific Evaluation Expert

These esteemed professionals shared valuable insights into the regulatory frameworks governing medical devices, emphasizing their critical role in ensuring product safety and compliance.

Workshop Overview:

Participants engaged in two interactive sessions covering a wide range of topics:

• SFDA's Role in Medical Devices: Understanding regulatory oversight and its significance.
• Risk Classification Rules: Navigating medical device classification for compliance.
• Clinical Evaluation: Approaches to evaluating safety and efficacy.
• Benefit-Risk Analysis: Risk management strategies for medical devices.
• Verification and Validation: Ensuring product integrity and adherence to standards.
• Innovative Pathways: Exploring advancements in medical device development.

The event provided a platform for attendees to ask questions, interact with industry leaders, and gain practical knowledge applicable to their academic and professional endeavors.

The Bioengineering Department at KFUPM remains committed to fostering innovation, education, and collaboration in the biomedical field through such impactful events.