Regulation of Digital Health Products (Classroom & Asynchronous)
Training Provider: NATIONAL UNIVERSITY OF SINGAPORE
Course Reference: TGS-2024043276
S$1,620
Original: S$5,400
Save S$3,780
About This Course
Through this course, students will learn to describe and differentiate the relevant standards and guidance required in Digital Health products verification and validation. Students will also be acquainted with the regulatory activities through medical device software development, testing and documentation, and will be able to describe key regulatory considerations in product life cycle including change management and post-market activities.
What You'll Learn
In today’s digital world, technologies and software play an increasingly important role in healthcare management - diagnosis, treatment, patient monitoring and Real World Data collection. While software-based medical devices products are currently controlled via medical device regulation, they differ significantly from traditional medical devices requiring a more streamlined and efficient regulatory oversight. Software standards and guidelines published by standards development organisations, particularly the International Organization for Standards (ISO) and International Electrotechnical Commission (IEC) and regulatory agencies/forums are important tools for effective governance for safe, quality and efficacious health products and timely access for patients. This 4-credit module provides the foundation in understanding established standards, guidelines and regulatory principles on conformity assessment of medical device software.
Entry Requirements
1. Bachelor's Degree.
2. Relevant experience in the field of health products regulatory affairs
Course Details
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