Course Overview
Introduces device design and development, standards and regulation. Emphasizes engineering design control issues based on the FDA's Quality System Requirements (21CFR820.30). Consists of three modules: The first module provides an overview, discusses product life cycle models and compares medical device regulations and standards applicable in Canada, the US and Europe. The second module focuses on design control. Topics include project planning, hazard analysis, design input/output, verification/validation, and design reviews. Lessons are reinforced with medical device design examples. The third module addresses design documentation, design transfer and post-design activities. Specifically emphasizes the basic design control concepts that are applicable to system and hardware design and could form the basis for software design.
Prerequisite(s)
- BMET Diploma (a technical diploma is desirable) or similar Diploma or Degree or with special permission of the Program Head.
Credits
3.0
- Retired
- This course has been retired and is no longer offered. Find other Flexible Learning courses that may interest you.
Learning Outcomes
Upon successful completion of this course, the student will be able to:
- Define all phases of the medical device life cycle.
- Understand the medical device regulatory environment.
- Summarize the Canadian, U.S. and European medical device regulations.
- Understand the medical device standards environment.
- List medical device standards organizations and be able to reference and locate them.
- Describe how IEC 60601 series of standards are structured.
- Critically review all phases of the medical device development.
- Analyze all elements of design control.
- Discuss all elements that are part of a design planning document for a medical device.
- Write requirements of a simple medical device, and assess the completeness of the requirement.
- Carry out an architectural design of a simple medical device.
- Analyze the methods for design input/output.
- Analyze the methods for verification and validation.
- Analyze the methods for hazard analysis for risk management.
- Define the issues relating to design transfer.
- Understand how various design activities relate to each other and the regulatory environment.
- List post-design activities relating to the Canadian, U.S. and European regulatory environment.
Effective as of Fall 2003
Programs and courses are subject to change without notice. Find out more about BCIT course cancellations.