Category: Chicago / Turabian

The Medical Device Single Audit Program (MDSAP) was developed in 2012 with the goal of creating a system where a single audit could be accepted across multiple jurisdictions. The program covers certification for ISO 13485 and also includes country-specific regulatory requirements, and provides many benefits to manufacturers including saving time and money. MDSAP is executed and utilized by a consortium of five regulatory bodies across five countries Australia (TGA), Brazil (ANVISA), Canada (Health Canada), U.S.A (FDA) and Japan (PMDA). If a manufacturer sells its device to all five participating countries, then the manufacturer must meet the QMS plus country-specific regulatory requirements of all five countries in order to be MDSAP certified.

Health Canada currently utilizes the CMDCAS (Canadian Medical Devices Conformity Assessment System) certificate per ISO 13485 as part of its medical device licensing process. MDSAP is not mandated by Australia, Japan, Brazil and the USA; however, as of January 1st 2019, Health Canada requires an MDSAP certificate from the manufacturer (or show proof that they are on track to be certified) to be able to market any medical devices in Canada and to maintain active device licenses.

Please review the following links and answer the questions below:

http://www.fda.gov/Training/CDRHLearn/ucm372921.htm
http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm
https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm621589.htm
http://www.imdrf.org/documents/documents.asp
Discuss in your post all the following questions and include references.

1. Discuss and justify at least three pros and cons of the MDSAP program from the perspective of both the manufacturer and the involved regulatory bodies.
2. Do you think it is reasonable for Health Canada to mandate MDSAP requirement to market medical devices while it is not required in other markets – Justify why or why not.
3. What might be the potential consequences of the MDSAP mandate for both the Canadian healthcare industry and the Canadian citizens/healthcare consumers?

TEXTBOOKS REQUIRED FOR THE PAPER

1. Livermore, David. Leading with Cultural Intelligence: The Real Secret to Success. 2nd ed. New York: AMACOM, 2015. ( READ CHAPTERS 1 – 4 )

2.  Toomey, Stella T., and Leeva C. Chung. Understanding Intercultural Communication. 2nd ed. New York: Oxford University Press, 2012. ( READ CHAPTER 1  – 3 )

RESEARCH PAPER: PART 1 INSTRUCTIONS
You will be required to write a 1,000-word evaluation of your personal cultural intelligence in current Turabian format.

You must support your assertions with a minimum of 1 textbook resource and 1 reference to your personal CQ Assessment report.

You will be required to identify strengths and areas where there is opportunity for growth while also proposing a plan for continuing to increase your CQ.

You will include an introduction of a minimum 250-words and an evaluation of a minimum of 750-words in addition to a title page, table of contents and bibliography citing both references. You will add to your bibliography with the completion of each part of the research paper.

NOTE: For the CQ Assessment paper Report, see it under the MY CQ REPORT, Open it and do the needful, and also for the strenghts and weeknesses also, you need to get it under my CQ Report also,

NOTE: PLEASE do not apply for this paper if you do not have access to the textbooks mentioned above in the reading textbooks please. Thanks.

TEXTBOOK READINGS FOR THE PAPER

1. Livermore, David. Leading with Cultural Intelligence: The Real Secret to Success. 2nd ed. New York: AMACOM, 2015. ( READ CHAPTERS 4 – 5 )

2.  Toomey, Stella T., and Leeva C. Chung. Understanding Intercultural Communication. 2nd ed. New York: Oxford University Press, 2012. ( READ CHAPTER 2 AND 3 )

BIBLE READINGS NEEDED FOR THE PAPER

1. ROMANS CHAPTERS 4 AND 5

DISCUSSION BOARD INSTRUCTIONS

You are required to provide a thread in response to the provided prompt for each forum. Each thread must be at least 500 words and demonstrate course-related knowledge and be supported by:

1.  2 textbook citation

2.  1 outside academic resource, and

3.  1  Biblical citation.

DISCUSSION BOARD FORUM 2 QUESTIONS

1. Topic: The Role of Cultural Values and How They Shape and Limit Intercultural Communication

QUESTIONS:

1.  What limitations do you face in intercultural communication and

2.  How is this shaped by preferred cultural values?

NOTE: Please only apply for the paper if you have access to the textbooks required for the paper as above pls.