National University of Sciences and Technology
Home | Back
BMES-812 Medical Devices Design and Standards
Campus SMME
Programs PG
Session Fall Semester 2016
Course Title Medical Devices Design and Standards
Course Code BMES-812
Credit Hours 3
Pre-Requisutes None
Course Objectives
  • To gain practical knowledge about intellectual property, standards and regulations, and their relationship to quality health care and associated biomedical technology.
  • Knowledge on medical device design, product development, quality assurance, and regulatory requirements and techniques is an essential part of every medical device development process. To address the important issues related to developing and using a safe and reliable medical device, and to understand how to meet regulatory requirements. Patent defense and intellectual property protection will be introduced.
Detail Content
  • Basic knowledge on intellectual property such as patents copyrights and trademarks. U.S. Patent system, European Patent Convention, China patent system, other patent systems, Patent Treaties. Patent search and patent filling procedures. Copyright ownership and protection. Introduction to medical devices, classifications, Hazard, safety and risk analysis of medical device,
  • Medical device standards and regulations, domestic standards, ISO standards, international standards (China/FDA/European (BSI, CEN, DIN, etc)), specifying and designing the products, testing and data analysis, medical device labeling, medical device directives.
  • Biocompatibility, Ethical issues on clinical research about medical devices on human subjects.
  • Designing the medical product, six sigma and product design, hardware design, software design, standard tests, hardware verification and validation.
  • With the assistance of faculty, students finalize product designs or complete detailed design evaluations of new medical products and bioethics issues.
Course Outcomes
  • At the end of the course the students will have knowledge about intellectual property, standards and regulations, and their relationship to quality health care and associated biomedical technology.
Text/Ref Books
  • comment:  RL 93/42/EG, 21 CFR 803, 806 and 820, FDA, ISO, electrical safety
  • Reliable design of Medical Devices by Richard Fries
  • comment:  RL 93/42/EG, 21 CFR 803, 806 and 820, FDA, ISO, electrical safety
  • Reliable design of Medical Devices by Richard Fries
Time Schedule
Faculty/Resource Person Lec Dr Umer Ansari