{"id":56969,"date":"2023-08-28T17:10:56","date_gmt":"2023-08-28T17:10:56","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/cbm353-medical-device-design-syllabus-for-mee-2021-regulation-professional-elective-ii\/"},"modified":"2023-08-28T17:10:56","modified_gmt":"2023-08-28T17:10:56","slug":"cbm353-medical-device-design-syllabus-for-mee-2021-regulation-professional-elective-ii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/cbm353-medical-device-design-syllabus-for-mee-2021-regulation-professional-elective-ii\/","title":{"rendered":"CBM353: Medical Device Design syllabus for MEE 2021 regulation (Professional Elective-II)"},"content":{"rendered":"

Medical Device Design detailed syllabus for Medical Electronics (MEE) for 2021 regulation curriculum has been taken from the Anna Universities<\/a> official website and presented for the MEE 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. <\/p>\n

For Medical Electronics 5th Sem scheme and its subjects, do visit MEE 5th Sem 2021 regulation scheme<\/a>. For Professional Elective-II scheme and its subjects refer to MEE Professional Elective-II syllabus scheme<\/a>. The detailed syllabus of medical device design is as follows. <\/p>\n

Course Objectives:<\/h4>\n

Download the iStudy App for all syllabus and other updates.<\/a>
\"Get<\/a><\/h4>\n

Unit I<\/h4>\n

NEEDS FINDING AND CONCEPT GENERATION
\nStrategic 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.
\nSafety and Risk Management – Tools, Documents and Deliverables.\n<\/p>\n

Unit II<\/h4>\n

MEDICAL DEVICES STANDARDS AND REQUIREMENTS
\nFDA, Medical devices classification, Medical Devices Directive Process – Harmonized Standards, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304. Reliability, Concept of failure, Product Design and Development Process.\n<\/p>\n

Unit III<\/h4>\n

Download the iStudy App for all syllabus and other updates.<\/a>
\"Get<\/a><\/h4>\n

Unit IV<\/h4>\n

TESTING AND VALIDATION
\nBasis and Types of Testing, Hardware Verification and Data Analysis, Software Verification and Data Analysis.\n<\/p>\n

Unit V<\/h4>\n

DESIGN TRANSFER AND MANUFACTURING
\nTransfer to Manufacturing, Hardware Manufacturing, Software Manufacturing, Configuration Management, Intellectual Property-Copy Rights-Trademarks-Trade Secrets. Case Study.\n<\/p>\n

Course Outcomes:<\/h4>\n

On successful completion of this course, the student will be able to<\/p>\n

    \n
  1. Define the medical devices standards and requirements.<\/li>\n
  2. Summarise the concept of medical device development.<\/li>\n
  3. Recall the engineering design and project metrics.<\/li>\n
  4. Demonstrate the testing and validation of medical equipment.<\/li>\n
  5. Interpret the various design transfer and manufacturing methods.<\/li>\n<\/ol>\n

    Text Books:<\/h4>\n

    Download the iStudy App for all syllabus and other updates.<\/a>
    \"Get<\/a><\/h4>\n

    Reference Books:<\/h4>\n
      \n
    1. Richard C. Fries and Marcel Dekker AG, Handbook of Medical Device Design,2ndedition, 2005.<\/li>\n
    2. Gail Baura, Medical Device Technologies: A Systems Based Overview Using Engineering, Elsevier science, 2012.<\/li>\n
    3. Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau\u2019Handbook of Human Factors in Medical Device Design\u2018,CRC press,2010.<\/li>\n
    4. Jagdish Chaturvedi, Inventing medical devices: A perspective from India, Create Space Independent Publishing Platform, 1st edition, 2015.<\/li>\n<\/li>\n<\/ol>\n

      For detailed syllabus of all the other subjects of Medical Electronics 5th Sem, visit MEE 5th Sem subject syllabuses for 2021 regulation<\/a>. <\/p>\n

      For all Medical Electronics results, visit Anna University MEE all semester results<\/a> direct link. <\/p>\n","protected":false},"excerpt":{"rendered":"

      Medical Device Design detailed syllabus for Medical Electronics (MEE) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the MEE students. For course […]<\/p>\n","protected":false},"author":2297,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[148],"tags":[],"class_list":["post-56969","post","type-post","status-publish","format-standard","hentry","category-mee"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/56969","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/users\/2297"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/comments?post=56969"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/56969\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=56969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=56969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=56969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}