Medical Device Design detailed syllabus for Biomedical Engineering (BME) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BME students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biomedical Engineering 5th Sem scheme and its subjects, do visit BME 5th Sem 2021 regulation scheme. For Professional Elective-II scheme and its subjects refer to BME Professional Elective-II syllabus scheme. The detailed syllabus of medical device design is as follows.
Course Objectives:
Download the iStudy App for all syllabus and other updates.
Unit I
NEEDS FINDING AND CONCEPT GENERATION
Strategic Focus – observation and problem identification – Need statement development. Ideation and Brainstorming – concept screening, concept selection: intellectual property basics -reimbursement basics – business models – prototyping – final concept selection.
Safety and Risk Management – Tools, Documents and Deliverables.
Unit II
MEDICAL DEVICES STANDARDS AND REQUIREMENTS
FDA, Medical devices classification, Medical Devices Directive Process – Harmonized Standards, ISO 13485, ISO 14971, IEC 60601-1, IEC 2304. Reliability, Concept of failure, Product Design and Development Process.
Unit III
Download the iStudy App for all syllabus and other updates.
Unit IV
TESTING AND VALIDATION
Basis and Types of Testing, Hardware Verification and Data Analysis, Software Verification and Data Analysis.
Unit V
DESIGN TRANSFER AND MANUFACTURING
Transfer to Manufacturing, Hardware Manufacturing, Software Manufacturing, Configuration Management, Intellectual Property-Copy Rights-Trademarks-Trade Secrets. Case Study.
Course Outcomes:
On successful completion of this course, the student will be able to
- Define the medical devices standards and requirements.
- Summarise the concept of medical device development.
- Recall the engineering design and project metrics.
- Demonstrate the testing and validation of medical equipment.
- Interpret the various design transfer and manufacturing methods.
Text Books:
Download the iStudy App for all syllabus and other updates.
Reference Books:
- Richard C. Fries and Marcel Dekker AG, Handbook of Medical Device Design,2ndedition, 2005.
- Gail Baura, Medical Device Technologies: A Systems Based Overview Using Engineering, Elsevier science, 2012.
- Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau’Handbook of Human Factors in Medical Device Design‘,CRC press,2010.
- Jagdish Chaturvedi, Inventing medical devices: A perspective from India, Create Space Independent Publishing Platform, 1st edition, 2015.
For detailed syllabus of all the other subjects of Biomedical Engineering 5th Sem, visit BME 5th Sem subject syllabuses for 2021 regulation.
For all Biomedical Engineering results, visit Anna University BME all semester results direct link.