National University of Sciences and Technology
Home | Back
BMES-812 Medical Device Design and Standards
Campus SMME
Programs PG
Session Spring Semester 2017
Course Title Medical Device Design and Standards
Course Code BMES-812
Credit Hours 3-0
Pre-Requisutes Only for Engineering Students
Course Objectives To give those professionals working in the development and use of medical devices and health care clinics, 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. This subject is 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
  • Introduction to Pro Engineer
  • Pro- Engineer CAD tools for parts designing
  • Pro- Engineer Parts Assemblies
  • Pro- Mechanica Finite Element Analysis;
  • Electrical System designing in medical devices
  • Basic knowledge on intellectual property such as patents copyrights and trademarks.
  • Medical device standards and regulations
  • Domestic standards, ISO standards
  • International standards (China/FDA/European (BSI, CEN, DIN, etc))
  • Biocompatibility
  • Ethical issues on clinical research about medical devices on human subjects
  • Design Verification testing and data analysis
  • Medical device directives
Text/Ref Books RL 93/42/EG, 21 CFR 803, 806 and 820, FDA, ISO, electrical safety
Reliable design of Medical Devices by Richard Fries
Time Schedule Fall or Spring Semester
Faculty/Resource Person Umar Ansari
Discipline: Biomedical Engineering
Specialization: Medical device designing, Active implants