Medical Device Regulation Project Plan

This document outlines a project plan for understanding and analyzing medical device regulation. It includes defined aims and objectives, a comprehensive project management plan covering scope, time, cost, quality, communication, risk, and resources. The plan also features a work breakdown structure and Gantt chart to illustrate the project's timeline and stages. Finally, the document incorporates small-scale research using both qualitative and quantitative methods to explore existing knowledge about medical device regulation.

ASSIGNMENT 1 FRONT SHEET
Qualification BTEC Level 5 HND Diploma in Computing
Unit number and title Unit 06: Managing a Successful Computing Project
Submission date 11/23/20 20 Date Received 1st submission
Re-submission Date Date Received 2nd submission
Student Name NGUYEN TRUNG ANH Student ID BHAF190
Class Assessor name NGUYEN
Student declaration
I certify that the assignment submission is entirely my own work and I fully understand the consequences of pla
making a false declaration is a form of malpractice.
Student’s signature
Grading grid
P1 P2 P3 P4 M1 M2 D1

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 Summative Feedback:  Resubmission Feedback:
Grade: Assessor Signature: Date:
IV Signature:

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Table of Contents
A.Introduction ......................................................................................................................................................................... 4
B. Establish project aims, objectives, and timeframes based on the chosen theme. ............................................................... 4
I. Devise project aims and objectives for a chosen scenario (P1): .................................................................................... 4
1. Scenario............................................................................................................................................................................... 4
2. Corporate background ......................................................................................................................................................... 5
II. Produce a project management plan that covers aspects of cost, scope, time, quality, communication, risk and
resources (P2): ....................................................................................................................................................................... 6
1. Project Overview ................................................................................................................................................................ 6
2. Project scope and benefits ................................................................................................................................................... 8
3. Deliverable .......................................................................................................................................................................... 9
4. Project requirement (and Budget summary) ..................................................................................................................... 10
5. Risk factors. (Heilman, 2011) ........................................................................................................................................... 15
III. Produce a work breakdown structure and a Gantt chart to provide timeframes and stages for completion (P3):
.............................................................................................................................................................................................. 17
1, WBS: ................................................................................................................................................................................. 17
2, Gantt Chart: ....................................................................................................................................................................... 21
3. Recommendation and conclusion ..................................................................................................................................... 22
IV, Carry out small-scale research by applying qualitative and quantitative research methods (P4): ...................... 22
1, Primary Research: ............................................................................................................................................................. 22
2, Secondary Research: ......................................................................................................................................................... 28
V. Conclusion....................................................................................................................................................................... 29
C. References ........................................................................................................................................................................ 30

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A.Introduction
In this assignment, I will establish project aims, objectives and timeframes based on the chosen theme, and conduct
small-scale research, information gathering and data collection to generate knowledge to support the project.
B. Establish project aims, objectives, and timeframes based on the chosen theme.
I. Devise project aims and objectives for a chosen scenario (P1):
1. Scenario
With the rapid development of technology, the amount of new information from research
projects is increasing and faster. Today, the amount of medical information has doubled every
three years. It is estimated that if a doctor wants to update all medical information it must read 29
hours a day. In addition, big data sources, including data from electronic health records (EHR),
"omic" data - data on genetics (genomics), data on metabolism (metabolomics) and protein data
(proteomics), and sociology and lifestyle data are the sources of data that would not be useful if
not fully analyzed. The only solution to be able to access and use a huge amount of information
in the medical field is to use artificial intelligence (AI) technology. And the software to cater to
that need is our DBN software. The project established DBN will have time 72 months, include:
preparation of legal procedures, preparation of systems, Web Site Design, Home Page Design ...

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2. Corporate background
the time taken is 1 year and operating activities within 5 years
I and my team work at software company TechAI, specializing in designing AI-related software,
currently AI technology in Vietnam is not able to develop like other countries but I can say That
AI is the future of technology in Vietnam in particular and in the world in general.We have seen
AI technology present in products such as cars or housing work very well and in healthcare. It is
still a whole new field due to many risks because there are very few companies that can do this
in the world, while in Vietnam there is no one and the biggest challenge that our team can do. I
have to face the moment that I have to create a memory large enough to be able to store all
patient records and economic problems because this is a new and underdeveloped industry in
Vietnam. There are very few people who can venture to invest in our project

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II. Produce a project management plan that covers aspects of cost, scope, time, quality, communication
risk and resources (P2):
1. Project Overview
After 5 months of research and consideration. TechAI CEO proposed to set up a project to
design AI health diagnostic software and my team was assigned by the company's CEO to this
This project has two phases:
Design Phase: CEO has 16 months to build and put into operation projects, including Web
Site Design, Home Page Design, Implementation, Tests, Marketing
After being allowed BOD, the CEO announced the project, detailed as follows:
Project Name : AI health monitoring software
Location: Bach Mai hospital
Operating time: 72 months
Design: 16 months, from 18/10/2020 to 18/02/2022
Operating activities: 60 months, from 18/10/2021 to 18/10/2026
The budget must be spent on the project: 1,000,000,000VND
The name of the project manager (project manager): William Nguyen
The plan for the project: evaluating the feasibility and licensing
activities, space, decoration, design space, modeling activities,
recruitment activities and official opening . Detailed information
concerning the personnel project, according to the following
table
task. This project has two phases:
Design phase: CEO has 16 months to build and put into operation projects, including: Interface
Design, Database Creation, Implementation, Testing

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The role Name Position
Interface Design Loretta Designer
Database Creation Andy Database
Administrator
Test John Tester
Project manager William Nguyen CEO
The project sponsor Nguyen Tri Tuan Loc Chairwoman
Present project William Nguyen CEO

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Finally, the signatures of the participants
2. Project scope and benefits
The project is implemented on the basis of a bluezone application, but the difference in our products is that we can
diagnose all diseases other than covid-19. The project after completion, if possible, is not only the future of
technology but also the future of economics as I said it could greatly reduce the number of deaths caused b
misdiagnosis. Even in the future, there will be no cases of death due to medical errors occurring. Estimated revenue
of this application is worth about 1,500 billion.
Key element of success
• To meet compliance with the trend and target customer needs
• Board of Directors have extensive experience.
• Strong financial capacity
• Large scale customers.
• There is cooperation from the most developed countries involved in software development
• Hardware: computers, servers, etc.
• Software: Sublime text 3, XAMPP, SQL management studio, Visual Studio Code, etc.
Assumption
The financial parameters of the project is calculated as follows expectations:

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Product sales 1st year 950 units
Growth rate / year 25%
Operating time period 1 5 Years
The average sale price 6,000,000 VND
Price Growth rate 7% Year
Cost 88% Sale price
Inflation rate 6% Year
Operating Expenses 5.5% Revenue
VAT 10%
Corporate tax 20%
License tax 1,000,000 VND
Other expenses 0.8% Revenue
The cost of fixed assets and working
tools 100,000,000 VND
Advertising and marketing costs 0.40% Revenue
Equity investment 600,000,000 VND
Discount rate of investors 17% Year
Loans 400,000,000 VND
Loan period 5 Year
Fixed interest rate loans 12% Year
3. Deliverable
The goal of this project is to develop the health care industry as well as the technology of Vietnam. Does the handove
of the project correspond to phase 2:
Construction: Designing the interface to build the database, testing so that the software can be used at the Bach Mai
hospital (the testing site of our company's software) on October 8, 2021
Operational activities: project efficiencies, ie ability to diagnose diseases, analyze and provide the fastest treatment
methods.

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4. Project requirement (and Budget summary)
Total cost of the project (based on the data sheet referred to in paragraph assumption)
Build: 100,000,000 VND
Operating activities: The total cost for 5 years of operation: 3,817,897,362 VN Total investment of
the project is 1,000,000,000 VND. In particular, equity: 600 million VND, 400 million VND loans.
Project management office / communication
HR organizational chart of the project are as follow : Cost Management. (Harrin, 2007)
Total cost expenses of project = Operation expense + Ads and marketing expense+ The cost of
fixed assets and working tools + License tax expense+ Other expense.
Some items of the project costs
1.1.1 Start-up Expenses 1.1.2
License tax expense 1,000,000
Others expenses for company
establishment 4,000,000
Total Start-up Expenses 5,000,000
Item Year 1 Year 2 Year 3 Year 4 Year 5
Operation expense 313,500,000 419,482,800 561,058,245 750,314,337 1,003,545,425
Ads and marketing
expense 22,800,000 30,507,840 40,804,236 54,568,315 72,985,122
The cost of fixed assets
and working tools 100,000,000
License tax expense 1,000,000 1,000,000 1,000,000 1,000,000 1,000,000
Other expense 45,600,000 61,015,680 81,608,472 109,136,631 145,970,244
Total cost expenses of
project 482,900,001 512,006,322 684,470,956 915,019,287 1,223,500,796

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1.1.3 Start-up Assets
Assets 95,000,000
Total Assets 95,000,000
Total Requirements 100,000,000
EMPLOYMENT COST
Position Quantity Monthly
salary
Manager 1 20,000,000
Accountant and purchasing 1 8,000,000
Sale and cashier 2 9,000,000
Security and dilivery 1 7,000,000
Cleaner 1 4,000,000
Total 6

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Assets Table Acquisition cost Useful life
Fixed assets 30,000,000
Deco the face 30,000,000 5
Selling & Administrative fixed
assets 65,000,000
1 Server 100,000,000 5
Table and chairs (6 packages) 10,000,000 5
Cashier machine - Casio SE-S10 3,500,000 5
Computer (4 unit) 35,000,000 5
Telephone (4 unit and FAX) 3,000,000 5
Table display products 3,500,000 5

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Rental and other cost
Item Month expenses
Rental cost 20,000,000
Start-up Expenses 416,667
Electric, water … cost 3,000,000
Quarterly promotion and advertising expense
Expenses Amount
Web design 10,000,000
Web maintenance 3,000,000
Promotion expenses 3,500,000
Total 16,500,000
The cost control measures
For procurement of fixed assets: implementation of public bidding to select the most suitable
supplier.
For personnel costs: clear assignment of tasks, regularly monitor and supervise work to achieve the
highest efficiency
About input goods: imported directly from the parent company

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Building savings culture: internal regulations issued on the use of work tools and supplies, regular
training, reminders, pasted slogans "to be rewarded save more" at the desk, public positions in the
company.
Quality management. (Heilman, 2011, p. 182)
Managing the quality of contracts signed
The contract concluded as: labor contracts, leases contractors, goods import contracts, leasing
contracts, contract design ... are accredited by the consulting firm PWC law, then CEO personally
verified and signed.
Quality management and surface construction progress
Examining the quality of drawings and textures in drawings, including:
Construction drawings showing the total surface solutions, architectural, structural, systems
engineering and technical infrastructure works for the size and volume of major construction;
Drawings prevention systems fire and explosion.
The requirement in the design process
Must have high feasibility, utility response and the legitimate requests of the investors, comply
with construction standards and regulations, use of materials and construction technologies
appropriate to the conditions of the area planning area.
Design works should be examined and approved by the CEO.
Business acquisition, transportation of materials, equipment, goods
This work requires close supervision to ensure raw materials are sufficient and properly to avoid
affecting the progress of the project. CEOs will examine the offer price, the prestige of the
supplier to obtain raw materials, high-quality equipment with the most reasonable cost. All
information on costs should be reported to the accounting department for timely updates and
respond immediately to any costs incurred beyond the company.
Regular inventory minimum inventory, ensuring stockpiles sufficient for 1 month of sales, avoid
insufficient supply of goods to the market
Effective Project Management
Periodically, week, month, quarter or year. The relevant departments will report the progress of
completing the plan in terms of revenue, expenses and profit to the CEO review, assess and plan
adjustments

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Organizational assignments
Develop a clear organizational chart, with modern test systems, precision and use workers
efficiently, solve timely policy regime. Job evaluation criteria are standardized, fair remuneration
policy, human resource planning, ensuring the right people, the details are as follows
Mr William Nguyen - CEO and PM, the main charge: Project Browser, recruitment policy
customers, cash flow management, daily operations ... Contact Phone: [phone].xx
Mr Nguyen Quoc Viet - business manager: responsible for finding space, decoration, design,
business begins, construction and implementation of business strategy and marketing. Phone
contact: 0905.11.55.xx
Mr Nguyen Tri Nam - CFOs, accountants responsible for licensing activities, procurement of tools
and supplies business, accounting and storage of accounting documents, Phone contact:
0908.06.86. xx
Consulting department, directly under the sales manager, in charge of sales Consulting, business
promotion
Warehouse department, directly under the director, responsible sourcing, warranty charge, perform
assigned KPIs,
The general rule is that each divisions, each member of the company have a job description and
clear KPIs, not overlap with each other
5. Risk factors. (Heilman, 2011)
Risk
code
Risks Measure Cause Workarounds
R001 Staffing Decline in
staff
numbers
- Disagreements
- Inappropriate
Capacity
- Objective reasons
force majeure
circumstances
- Require members to set up
daily work diary.
- Upgrade team members to
replace or recruit new
members.
- Take the project objectives
to guide main.
R002 Delay
progress
late deadline - Members not
complete on
Cause analysis,
- If so subjective, it must be
timely correction, there are

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schedule assigned
tasks
- Slow progress due
to external
stakeholders: state
agencies, partners
...
- The force majeure
by natural
disasters, enemy
sabotage
sanctions depending on the
severity.
- If so objective , because
the subject is outside of
contracts signed to settle
and extend deadline
- To supervise and control
deadlines, daily, weekly to
capture and provide
appropriate solutions.
R003 Declining
revenues
than
planned
Reduced
sales
volume,
revenue
decreased
- Customer Policies
are inappropriate
- The policy of
unsuitable sales
- Pricing policy is
inappropriate
- Position trading is
not appropriate
- Improved customer policy
- Improved sales policy and
customer care
- Review of pricing policy
- Change the selected
position, enhance brand
positioning

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III. Produce a work breakdown structure and a Gantt chart to provide timeframes and stages for completion
(P3):
1, WBS:
1.1, Definition:
Breaking work into smaller tasks is a common productivity technique used to make work more manageable
and approachable. For projects, the Work Breakdown Structure (WBS) is the tool that utilizes this technique and is
one of the most important project management documents. It integrates scope, cost and schedule baselines ensuring
that project plans are alignment.
The Project Management Institute (PMI) Project Management Book of Knowledge (PMBOK) defines
WBS as a “deliverable oriented hierarchical decomposition of the work to be executed by the project team”. There are
two types of WBS: Deliverable Based and Phase Based.
1.2, WBS for the project:
For this project, I will be using the phase based WBS to demonstrate the process of building the system.

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Phase Work Persons
performed
Project
timeline
1. Definition 1. Cause established project
2. Kick-off project
3. Do Project Charter
4. Do Scope Statement
5. Review & Approve
PM – Willam
Nguyen
18/09/2020
18/10/2020
2. Planning 1. Evaluation of financial performance
2. Evaluation of customer segments
3. Evaluation of the ability to meet HR
4. Evaluation of the financial capacity of the owner,
the ability to borrow
5. Evaluation of conformity than stipulated by law
6. Evaluation of project risks and risk mitigation
plans
7. Evaluation of the current resources of the company
8. Review & Approve
PM
BOD
25/09/2020
5/10/2020
3. Execution Build
1. Establishment of project HR
2. meetings, assign tasks
3. Rent premises and design, decoration
4. Getting a permission on operation
5. Sign contracts with hospital, register copyright
for software ...
PM
Nguyen Quoc
Viet
Nguyen Tri
Nam
18/10/2020
18/11/2020
21/11/2020
18/1/2021

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6. Develop customer policy
Operating activities
1. To assign engineers with highest expertise to be
on duty at test site 24/24
2. Train medical staff of the hospital to use
the software
3. Recruit HR if necessary
4. Synthesis, reports, recommendations
PM 18/2/2021
CEO 19/3/2021
End year
annual
financial
4. Delivery Build
1. Handing over the business licenses software
copy license and legal records
2. Handing over detailed software, tools and supplies
3. The contract for electricity, water, telephone ...
4. Hand over the minutes of the meeting, the
problems, the difficulties, the proposed
requirements of the stakeholders in the process of
establishment
PM
CEO
18/10/2021
18/10/2026
Operating activities
1. Handing over the business results of the project
2. Handing over of personnel, the personnel
decisions, the personnel policy during 5 years
of operation
3. Handove of patient information facility

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2, Gantt Chart:
2.1, Definition:
A Gantt chart is a graphical depiction of a project schedule. It’s a type of bar chart that shows the start and
finish date of several elements of a project that includes resources, milestones, tasks and dependencies.
A Gantt chart helps in scheduling, managing and monitoring specific tasks and resources in a project. The char
shows the project timeline, which includes scheduled and complete work over a period. The Gantt chart helps project
managers in communicating project status or plans and also helps ensuring the project remains
Allocate time in the project life cycle
2.2, Gantt Chart for the project:
No Stage Total times work
(Unit: day)
1 Definition 30
2 Planning 150
3 Execution
Stage 1
Stage 2
1,976
150
1,826
4 Delivery
Build
Operating activities
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3
10

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3. Recommendation and conclusion
This is a project of low investment value, but the idea of it can extend throughout the territory of
Vietnam and can even extend to the world.
With financial strength and experience of corporate management as well as financial performance
brought by the project, Huwe fully confident in the viability of this project.
, Conduct small-scale research, information gathering and data collection to generate knowledge to suppor
the project:
IV, Carry out small-scale research by applying qualitative and quantitative research methods (P4):
1, Primary Research:
Primary research is defined as a methodology used by researchers to collect data directly, rather than dependin
on data collected from previously done research. Primary research is solely carried out to address a certain problem,
which requires in-depth analysis.
Businesses or organizations can conduct primary research themselves or employ a third party to cond
research on their behalf. One of the major benefits is this type of research is “pinpointed” which means that the researc
is carried around only a specific issue or problem and all the focus is directed to obtain related solutions.
For this project my team will use two of the methods most commonly used for primary research: Interview and
Survey.
1.1, Interview:
For the interview, my team will be interviewing the Professor of Medical Devices at University of Wales
Trinity Saint David, Caerwyn Ash, Medical Devices Sales, Clement Hayes, and Doctor Kiri Herman. The interviewin
process will be ranging from October 28th to November 4th.
1.1.1, List of interview questions:
Below are some of the questions I have designed questions for the interview, which include opened questions
and closed questions.

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Types of Questions Questions
Opened-ended Questions How would you define medical accident ?
How many people died in medical accidents in our country a year?
How would you describe the effectiveness of pre-test diagnoses?
Have you or any of your loved ones ever had a medical accident?
Closed-ended Questions Are you satisfied with our country’s medical technologies
If you were a hospital director would you want to consider bringing
our software to use in your hospital
In case doctors have used your software and still have errors in
medicine, who will be responsible?
FIGURE 1. LIST OF INTERVIEW QUESTIONS
1.1.2, Summary of interview:
After interviewing with the officers, my team has summarized the results and created the follow results:

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FIGURE 2. DEFINITION OF MEDICAL ACCIDENT
INTERVIEW REPORT
Interview notes approved by: Trung Anh
Person interviewed Gray Mathews
Interviewer Nguyen Dinh Thanh
Date October 29th, 2020
Primary Purpose: Definition of medical accident
Summary of Interview:
- Gathered information about medical accident from Nguyen Thanh Long(Minester Of
Health).

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FIGURE 3. MEDICAL ACCIDENT INTERVIEW REPORT
INTERVIEW REPORT
Interview notes approved by: Trung Anh
Person interviewed Nickson Browns
Interviewer Phan Van Thai
Date November 1st, 2020
Primary Purpose: Number of medicalerror case occured
Summary of Interview:
- Gathered information about medicalerror deaths from health department

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1.2, Survey:
1.2.1, List of survey questions:
For surveys, my team used Google Forms to design questions and forms for customers to participate and give
their opinions about their experience with the system. Below are the questions along with answers that users can apply

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FIGURE 4. SURVEY QUESTIONS
1.2.2, Survey summary:
1.3, Evaluation of interview and survey:
In primary research, I have used two methods to gather data: Interview and Survey. Through interviewing, I
was able to gather essential data to implement and develop the system. Through surveys, I was able to gather data
from customers using the system for enhancing the overall experience for the customer and to continue developing
and maintaining the system. The overall results of both methods were exceeding expectations and I have gathered
useful information of medical devices, along with opinions of customers about these types of products.
2, Secondary Research:
Secondary research is a common approach to a systematic investigation in which the research depends solely
on existing data in the course of the research process. This research design involves organizing, collating and analyzin
these data samples for valid research conclusions.

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Advantages Disadvantages
Easy to access. Hard to determine the authenticity of the data
due to the researcher is not directly involved in
the research process.
Cost-effective and not time-consuming. The data obtained by secondary research is
unspecific in nature and may not directly cater
to the needs of the researcher.
Helps researchers to identify knowledge gaps. The research materials are not exclusive,
which means everyone can access the data.
Useful for mapping out the scope of research
thereby setting the stage for field
investigations.
There is a risk of encountering outdated
research materials.
FIGURE 5. ADVANTAGES AND DISADVANTAGES OF SECONDARY RESEARCH
2.1, Lists of articles/books:
For secondary research, I have chosen two articles to aid me with the system:
2.2, Summarize about articles/book you have read:
2.2.1, Article: The regulation of medical devices and the role of the Medical Devices Agency
This article provides in-depth details of the development of Devices Regulation, the current regulation
medical devices, the role of the Medical Devices Agency (MDA), post market surveillance, evaluation programme,
international functions, comparison with pharmaceutical authorization procedures, the medical device/medicinal
product interface and the future of medical devices.
2.2.2, Article: Impact of regulations on innovation in the field of medical devices
This article provides details of the background on Medical Devices Regulations, the innovation in the Medical
Devices Sector, effects of Regulations on Innovation in Medical Devices and analysis of innovative medical
technologies cases which include nanomaterials and materials for tissue engineering and 3D-bioprinting.
2.3, Evaluation about your understanding:
From the two articles mentioned above, I was able to understand the background and development of Medical
Devices Regulations, the regulation of medical devices, the role of the Medical Devices Agency (MDA), the
innovation of the Medical Devices Sector, the future of medical devices and analysis of innovative medical
technologies.
Due to the deadline, I wasn’t able to fully understand the post market surveillance, evaluation programme,
international functions, comparison with pharmaceutical authorization procedures, the medical device/medicinal
product interface, effects of Regulations on Innovation in Medical Devices.
If I had more time, I will have a more in-depth research about the international functions, the medic
device/medicinal product interface and effects of Regulations on Innovation in Medical Devices along with a better
research for other sections I wasn’t fully understand.
V. Conclusion
In this assignment, I have devised project aims and objectives for a chosen scenario, produced a project management plan that
covers aspects of cost, scope, time, quality, communication, risk and resources, produced a work breakdown structure and a
Gantt chart to provide timeframes and stages for completion and carried out small-scale research by applying qualitative and
quantitative research methods

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C. References
Harrin, E. (2007). Project Management in the Real World Shortcuts to success. UK: British
Informatics Society Limited (BISL).
Heilman, K. (2011). Project Management Jumpstart. In T. Tate, Project Management Jumpstart
(p. 144). Indiana: Wiley Publishing, Inc

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