Describe a complete diagnostic evaluation session. Include all measures that are administered from beginning to end giving details and examples. Explain why we perform each step of the evaluation and what information it gives us towards a diagnosis. How do the findings from the evaluation translate into a diagnostic report?

MERMED Inc. is a medical device manufacturer.

The company’s headquarters is located in Houston, Texas. It is a global leader in developing, manufacturing, selling and servicing diagnostic imaging and therapeutic medical devices used to diagnose and treat cardiovascular and other diseases. MERMED earned $300 million of revenue in 2015, while employing more than 10,000 people worldwide. One of it’s manufacturing plants is located in Dingle, Co. Kerry, Ireland. Tom Jones is the plant manager at the Dingle facility.

The Dingle site runs 12 hour shifts, 7 days a week. It has 1000 employees. It manufactures a variety of of medical devices (including Class III devices). A number of it's products are sold in the US and European markets. The facility has a Quality Management System in place. Their Quality Management System is in compliance with ISO 13485:2016 and 21 CFR 820. Their facility is frequently audited by Notified Bodies and the FDA.

The site was recently audited by corporate. The corporate auditing team were checking the site's compliance with ISO 13485:2016 and 21 CFR 820. The auditors found a number of potential non-conformances to  ISO 13485:2016 and 21 CFR 820.

You must complete 4 tasks (for each of the 5 incidents/questions):

1.   Review each of these potential non-conformances (5 incidents in total)

2. Determine if they are non-conformances against the requirements of the ISO13485:2016 AND 21 CFR 820.

3. If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

Note:  ISO 13485:2016 and 21 CFR 820 are available in the "Additional Resources" section, under the section heading "Quality Systems Regulations (EU and US)" (contained within Section A Medical Device Regulatory Affairs).

4. Briefly EXPLAIN your decision in 100-170 words.

QUESTION 4

The operation of a weighing scale (equipments ID 186749) was reviewed by the inspector in the Box Packing section. The weighing scale was in use during the current shift. The operating procedure (SOP18654) for the scale states that it must be calibrated at the beginning and end of each shift. The operating procedure states that that the calibration of the scales is recorded in a log book(Calibration Log for ID 186749 ). The inspector asked to review this log book. The maintenance technician who was interviewed said that the log book was held by the maintenance technician on the night shift and he always kept it in his desk drawer which was locked.

MERMED Inc. is a medical device manufacturer.

The company’s headquarters is located in Houston, Texas. It is a global leader in developing, manufacturing, selling and servicing diagnostic imaging and therapeutic medical devices used to diagnose and treat cardiovascular and other diseases. MERMED earned $300 million of revenue in 2015, while employing more than 10,000 people worldwide. One of it’s manufacturing plants is located in Dingle, Co. Kerry, Ireland. Tom Jones is the plant manager at the Dingle facility.

The Dingle site runs 12 hour shifts, 7 days a week. It has 1000 employees. It manufactures a variety of of medical devices (including Class III devices). A number of it's products are sold in the US and European markets. The facility has a Quality Management System in place. Their Quality Management System is in compliance with ISO 13485:2016 and 21 CFR 820. Their facility is frequently audited by Notified Bodies and the FDA.

The site was recently audited by corporate. The corporate auditing team were checking the site's compliance with ISO 13485:2016 and 21 CFR 820. The auditors found a number of potential non-conformances to  ISO 13485:2016 and 21 CFR 820.

You must complete 4 tasks (for each of the 5 incidents/questions):

1.   Review each of these potential non-conformances (5 incidents in total)

2. Determine if they are non-conformances against the requirements of the ISO13485:2016 AND 21 CFR 820.

3. If they are non-compliances, write down the specific clause numbers in ISO 13485:2016 AND specific section number of 21 CFR 820 which is applicable (write down the main clause/section in each regulation that the non-compliance is against).

Note:  ISO 13485:2016 and 21 CFR 820 are available in the "Additional Resources" section, under the section heading "Quality Systems Regulations (EU and US)" (contained within Section A Medical Device Regulatory Affairs).

4. Briefly EXPLAIN your decision in 100-170 words.

QUESTION 4

The operation of a weighing scale (equipments ID 186749) was reviewed by the inspector in the Box Packing section. The weighing scale was in use during the current shift. The operating procedure (SOP18654) for the scale states that it must be calibrated at the beginning and end of each shift. The operating procedure states that that the calibration of the scales is recorded in a log book(Calibration Log for ID 186749 ). The inspector asked to review this log book. The maintenance technician who was interviewed said that the log book was held by the maintenance technician on the night shift and he always kept it in his desk drawer which was locked.

Wells Technical Institute (WTI), a school owned by Tristana Wells, provides training to individuals who pay tuition directly to the school. WTI also offers training to groups in off-site locations. Its unadjusted trial balance as of December 31, 2017, follows. WTI initially records prepaid expenses and unearned revenues in balance sheet accounts. Descriptions of items athrough h that require adjusting entries on December 31, 2017, follow.
  
Additional Information Items

1. An analysis of WTI's insurance policies shows that $3,203 of coverage has expired.
2. An inventory count shows that teaching supplies costing $2,776 are available at year-end 2017.
3. Annual depreciation on the equipment is $12,814.
4. Annual depreciation on the professional library is $6,407.
5. On November 1, WTI agreed to do a special six-month course (starting immediately) for a client. The contract calls for a monthly fee of $2,700, and the client paid the first five months' fees in advance. When the cash was received, the Unearned Training Fees account was credited. The fee for the sixth month will be recorded when it is collected in 2018.
6. On October 15, WTI agreed to teach a four-month class (beginning immediately) for an individual for $3,600 tuition per month payable at the end of the class. The class started on October 15, but no payment has yet been received. (WTI's accruals are applied to the nearest half-month; for example, October recognizes one-half month accrual.)
7. WTI's two employees are paid weekly. As of the end of the year, two days' salaries have accrued at the rate of $100 per day for each employee.
8. The balance in the Prepaid Rent account represents rent for December.

Required:
1. Prepare the necessary adjusting journal entries for items a through h. Assume that adjusting entries are made only at year-end.

2-a. Post the balance from the unadjusted trial balance and the adjusting entries in to the T-accounts.
2-b. Prepare an adjusted trial balance.

3-a. Prepare Wells Technical Institute's income statement for the year 2017.
3-b. Prepare Wells Technical Institute's statement of owner's equity for the year 2017.
3-c. Prepare Wells Technical Institute's balance sheet as of December 31, 2017.

Wells Technical Institute (WTI), a school owned by Tristana Wells, provides training to individuals who pay tuition directly to the school. WTI also offers training to groups in off-site locations. Its unadjusted trial balance as of December 31, 2018, follows. WTI initially records prepaid expenses and unearned revenues in balance sheet accounts. Descriptions of items a through h that require adjusting entries on December 31, 2018, follow.
  
Additional Information Items

1. An analysis of WTI's insurance policies shows that $2,400 of coverage has expired.
2. An inventory count shows that teaching supplies costing $2,800 are available at year-end 2018.
3. Annual depreciation on the equipment is $13,200.
4. Annual depreciation on the professional library is $7,200.
5. On November 1, WTI agreed to do a special six-month course (starting immediately) for a client. The contract calls for a monthly fee of $2,500, and the client paid the first five months' fees in advance. When the cash was received, the Unearned Training Fees account was credited. The fee for the sixth month will be recorded when it is collected in 2019.
6. On October 15, WTI agreed to teach a four-month class (beginning immediately) for an individual for $3,000 tuition per month payable at the end of the class. The class started on October 15, but no payment has yet been received. (WTI's accruals are applied to the nearest half-month; for example, October recognizes one-half month accrual.)
7. WTI's two employees are paid weekly. As of the end of the year, two days' salaries have accrued at the rate of $100 per day for each employee.
8. The balance in the Prepaid Rent account represents rent for December.
   

1) Prepare the necessary adjusting journal entries for items a through h. Assume that adjusting entries are made only at year-end.

2A) Post the balance from the unadjusted trial balance and the adjusting entries into the T-accounts.
2B) Prepare an adjusted trial balance.

3A)Prepare Wells Technical Institute's income statement for the year 2018.
3B) Prepare Wells Technical Institute's statement of retained earnings for the year 2018.
3C) Prepare Wells Technical Institute's balance sheet as of December 31, 2018.

Looking around do you believe Code of Ethics even matters? We see individuals violating their own Code for small things. For example I am a thief. I still from University. When I teach on ground classes I have gone home with Dry Erase markers and have used them at home and not brought them back. During work time I check my personal emails. What about these actions?

A university is trying to determine what PRICE to charge for football tickets. At a price of $6 per ticket, it averages 70,000 people per game.
For every increase of $1, it loses 10,000 people from the average number . Every person at the game spends an average of$1.50 on concessions.

a) What price per ticket should be charged to MAXIMIZE REVENUE? ( Please explain the steps )

b) How many people will attend at that price? Please show your work.

A class survey in a large class for first-year college students asked, "About how many hours do you study in a typical week?". The mean response of the 427 students was x¯¯¯ = 12 hours. Suppose that we know that the study time follows a Normal distribution with standard deviation 7 hours in the population of all first-year students at this university. What is the 99% confidence interval (±0.001) for the population mean?

Confidence interval is from ____to_____ hours.

In your work as an accountant you advise a client, Avon Pty. Ltd. (Avon), on various matters. Avon entered into a $500,000 one year contract in June 2016 with Central Queensland University (a registered Research Service Provider) to undertake research and development for Avon. The contract was to run from July 2016 to June 2017. Avon wants your advice about tax offsets and how this expense could be treated by the ATO in the 2016-17 tax year.

Describe how the following transactions would affect U.S. exports, imports, and net exports:

1. Students in Prague flock to see the latest movie from Hollywood.
2. Mrs. Jones in Philadelphia buys a new Volvo.
3. The student bookstore at Oxford University in England sells a copy of a U.S. printed/authored textbook
4. A Canadian citizen shops at a store in northern Vermont to avoid Canadian sales taxes.
5. An American art professor spends the summer touring museums in Europe.